THERMACARE LOWER BACK & HIP
Report
- Report Number
- 1066015-2020-00133
- Event Type
- Injury
- Date Received
- June 24, 2020
- Report Date
- June 15, 2020
- Manufacturer
- PFIZER CONSUMER HEALTH CARE
- Product Code
- IMD
- PMA / PMN Number
- K953442
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
CONCLUSION: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS THE WRAP CAUSED "BURN BLISTER AFTER USE ON THE STOMACH." THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED BURN BLISTER IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT A DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID THE RISKS OF BURNS OR OTHER SKIN IRRITATIONS. OUR MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN-PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF THE BATCH DEVICE HISTORY RECORD, IN PROCESS ATTRIBUTES AND VARIABLE QUALITY CHECKS OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. SITE SAMPLE STATUS: NOT RECEIVED.
SUMMARY OF INVESTIGATION: BATCH# AR5204. DATE OF MANUFACTURE: 04-04-2019 TO 04-09-2019. BATCH AR5204 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THEREMACARE BATCHES ARE PRODUCED AS INDIVIDUAL LOTS. THE DEVICE HISTORY RECORD (DHR), RESERVE SAMPLES, AND TRENDING WERE EVALUATED. NO QUALITY ISSUES WERE IDENTIFIED.CONCLUSION: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS THE WRAP CAUSED "BURN BLISTER AFTER USE ON THE STOMACH." THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED BURN BLISTER IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT A DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID THE RISKS OF BURNS OR OTHER SKIN IRRITATIONS. OUR MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN-PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF THE BATCH DEVICE HISTORY RECORD, IN PROCESS ATTRIBUTES AND VARIABLE QUALITY CHECKS OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. LOT TREND ASSMT. & RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE FIRST COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/SERIOUS/UNKNOWN RECEIVED AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPED TREND ASSMT. & RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TREND FOR THIS SUBCLASS. EXPED TREND ACTIONS TAKEN: BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCT, REFER TO ATTACHMENT ADVERSE EVENT SERIOUS UNKNOWN LBH (B)(6) 2017 TO (B)(6) 2020. THERE WAS DEVIATION FROM SOP-105746, COMPLAINT TRENDING GUIDELINES, EFFECTIVE (B)(6) 2020 IN WHICH THE EXPEDITE TRENDING OF COMPLAINT INVESTIGATIONS WAS TRENDED FOR A 24-MONTH PERIOD INSTEAD OF A 36-MONTH PERIOD. THIS INVESTIGATION WAS REOPENED TO CORRECT THE TRENDING. THE RESULTS DO NOT CHANGE THE ROOT CAUSE OF THE COMPLAINT. CORRECTIONS WILL BE COMPLETED IN (B)(4), ACTION ITEM (B)(4). SITE SAMPLE STATUS: NOT RECEIVED. SEVERITY OF HARM WAS S3.
EVENT VERBATIM [PREFERRED TERM], BURN BLISTER [BURNS SECOND DEGREE], SHE TURNED THE PRODUCT TO THE FRONT AS SHE HAD STOMACH ACHE/ THERMACARE LBH HEATWRAP WAS USED FOR BLADDER CRAMPS [DEVICE USE ISSUE]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY PFIZER FROM (B)(4) (REFERENCE # (B)(4)). A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (LOT NUMBER: AR5204, EXPIRATION DATE: MAR2022), FROM AN UNSPECIFIED DATE AT AN UNKNOWN FREQUENCY FOR STOMACH ACHE AND BLADDER CRAMPS. MEDICAL HISTORY INCLUDED HAY FEVER. CONCOMITANT MEDICATIONS INCLUDED GINKGO BILOBA, PANAX GINSENG (GINCOSAN) FROM (B)(6) 2020. THE PATIENT WANTED TO TEST THE THERMACARE LBH HEATWRAP AND APPLIED IT ON HER BACK WHERE IT WORKED WELL. AFTER A WHILE SHE TURNED THE PRODUCT TO THE FRONT AS SHE HAD STOMACH ACHE, BUT AS SHE REMOVED THE PRODUCT, SHE HAD A BURN BLISTER. DATE THE ISSUE OCCURRED OR WAS IDENTIFIED WAS DURING THE NIGHT, APPROXIMATELY 6 TO 14 HOURS AFTER APPLICATION. IT WAS FURTHER STATED THAT THE FEMALE PATIENT WAS SUFFERING FROM HAY FEVER AND HAD NO RELEVANT MEDIAL TREATMENT. GINCOSAN, HAD BEEN TAKEN FOR 4 WEEKS,1X DAILY, AS A CONCOMITANT MEDICATION. THERMACARE LBH HEATWRAP (LOT NR. AR5204 / EXP MAR2022) WAS USED FOR BLADDER CRAMPS. THERMACARE LBH HEATWRAP WAS WORN ON THE STOMACH FOR APPROXIMATIVELY 4 HOURS. THE PATIENT EXPLAINED SHE HAD PREVIOUSLY APPLIED A CHERRY STONE PILLOWS ON HER STOMACH AND WAS IN A SITTING POSITION. THE REACTION OCCURRED DURING THE NIGHT, APPROXIMATELY 6 TO 14 HOURS AFTER APPLICATION. A SMALL BURN BLISTER APPEARED AT A SINGLE LOCATION. IT WAS A CLASSIC WOUND HEALING, WITH NO CONSEQUENTIAL DAMAGE. THE PATIENT TREATED THE BURN BLISTER WITH MERFEN AND BEPANTHEN. SAMPLE AVAILABILITY OR PICTURES WAS NO. THE ACTION TAKEN IN RESPONSE TO THE EVENT WAS UNKNOWN. THE EVENT OUTCOME WAS RECOVERED. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP, CONCLUSION: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS THE WRAP CAUSED "BURN BLISTER AFTER USE ON THE STOMACH." THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED BURN BLISTER IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT A DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID THE RISKS OF BURNS OR OTHER SKIN IRRITATIONS. OUR MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN-PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF THE BATCH DEVICE HISTORY RECORD, IN PROCESS ATTRIBUTES AND VARIABLE QUALITY CHECKS OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. SITE SAMPLE STATUS: NOT RECEIVED. SEVERITY OF HARM WAS S3. FOLLOW-UP (15JUN2020, 22JUN2020, 22JUN2020 AND 22JUN2020): THIS CASE IS BEING SUBMITTED TO NOTIFY THAT THE INITIAL INFORMATION FOR THIS CASE WAS FIRST RECEIVED BY THE COMPANY ON 15JUN2020 AND NOT ON 19JUN2020 AS PREVIOUSLY REPORTED. DUE TO SAFETY DATABASE TECHNICAL LIMITATIONS, THE FIELD "INITIAL RECEIPT DATE" (I.E., COMPANY FIRST AWARENESS DATE) CAN NO LONGER BE MODIFIED. THE FOLLOWING CLARIFICATION WAS RECEIVED FROM (B)(4): THE INITIAL RECEIPT DATE WAS 15JUN2020. THE RECEIPT DATE OF ALL FOLLOW-UP INFORMATION WAS 22JUN2020. NEW INFORMATION ALSO REPORTED FROM A CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY PFIZER FROM (B)(4) (REFERENCE # (B)(4)) INCLUDED: DEVICE INFORMATION (INCLUDING SAMPLE AVAILABILITY, LOT NUMBER AND EXPIRATION DATE), MEDICAL HISTORY, CONCOMITANT MEDICATION AND EVENT DETAILS. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (05JUL2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATION RESULTS. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED.
EVENT VERBATIM [PREFERRED TERM] BURN BLISTER [BURNS SECOND DEGREE], SHE TURNED THE PRODUCT TO THE FRONT AS SHE HAD STOMACH ACHE/ THERMACARE LBH HEATWRAP WAS USED FOR BLADDER CRAMPS [DEVICE USE ISSUE], NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY PFIZER FROM (B)(6) (REFERENCE # (B)(4)), LICENSE PARTNER FOR THERMACARE. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), FROM AN UNSPECIFIED DATE AT AN UNKNOWN FREQUENCY FOR STOMACH ACHE. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT WANTED TO TEST THE THERMACARE LBH HEATWRAP AND APPLIED IT ON HER BACK WHERE IT WORKED WELL. AFTER A WHILE SHE TURNED THE PRODUCT TO THE FRONT AS SHE HAD STOMACH ACHE, BUT AS SHE REMOVED THE PRODUCT, SHE HAD A BURN BLISTER. THE ACTION TAKEN IN RESPONSE TO THE EVENT WAS UNKNOWN. THE EVENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (22JUN2020): THIS IS A FOLLOW-UP REPORT FROM A CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY PFIZER FROM (B)(6) (REFERENCE # (B)(6)), LICENSE PARTNER FOR THERMACARE. THE FOLLOWING INFORMATION WAS REPORTED FOR THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), LOT NO. AR5204: DATE THE ISSUE OCCURRED OR WAS IDENTIFIED WAS "DURING THE NIGHT, APPROXIMATELY 6 TO 14 HOURS AFTER APPLICATION." SAMPLE AVAILABILITY OR PICTURES: NO. NO FOLLOW-UP ATTEMPTS NEEDED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (22JUN2020): THIS IS A FOLLOW-UP REPORT FROM A CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY PFIZER FROM (B)(6) (REFERENCE # (B)(6)), LICENSE PARTNER FOR THERMACARE. THE FOLLOWING DESCRIPTION WAS REPORTED FOR THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), LOT NO. AR5204: THE FEMALE PATIENT IS SUFFERING FROM HAY FEVER AND HAS NO RELEVANT MEDIAL TREATMENT. GINCOSAN HAS BEEN TAKEN FOR 4 WEEKS,1X DAILY, AS A CONCOMITANT MEDICATION. THERMACARE LBH HEATWRAP (LOT NR. AR5204 / EXP MAR2022) WAS USED FOR BLADDER CRAMPS. THERMACARE LBH HEATWRAP WAS WORN ON THE STOMACH FOR APPROXIMATIVELY 4 HOURS. THE PATIENT EXPLAINED SHE HAD PREVIOUSLY APPLIED A CHERRY STONE PILLOWS ON HER STOMACH AND WAS IN A SITTING POSITION. THE REACTION OCCURRED DURING THE NIGHT, APPROXIMATELY 6 TO 14 HOURS AFTER APPLICATION. A SMALL BURN BLISTER APPEARED AT A SINGLE LOCATION. IT WAS A CLASSIC WOUND HEALING, WITH NO CONSEQUENTIAL DAMAGE. THE PATIENT TREATED THE BURN BLISTER WITH MERFEN AND BEPANTHEN. FOLLOW-UP (22JUN2020): THE FOLLOWING CLARIFICATION WAS RECEIVED FROM LP-(B)(6): THE INITIAL RECEIPT DATE WAS 15JUN2020. THE RECEIPT DATE OF ALL FOLLOW-UP INFORMATION WAS 22JUN2020. FOLLOW-UP (15JUN2020): THIS CASE IS BEING SUBMITTED TO NOTIFY THAT THE INITIAL INFORMATION FOR THIS CASE WAS FIRST RECEIVED BY THE COMPANY ON 15JUN2020 AND NOT ON 19JUN2020 AS PREVIOUSLY REPORTED. DUE TO SAFETY DATABASE TECHNICAL LIMITATIONS, THE FIELD "INITIAL RECEIPT DATE" (I.E., COMPANY FIRST AWARENESS DATE) CAN NO LONGER BE MODIFIED. NO FOLLOW-UP ATTEMPTS NEEDED. NO FURTHER INFORMATION EXPECTED.
EVENT VERBATIM [PREFERRED TERM] BURN BLISTER [BURNS SECOND DEGREE], SHE TURNED THE PRODUCT TO THE FRONT AS SHE HAD STOMACH ACHE/ THERMACARE LBH HEATWRAP WAS USED FOR BLADDER CRAMPS [DEVICE USE ISSUE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY PFIZER FROM ANGELINI, LICENSE PARTY FOR THERMACARE HEATWRAP. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (LOT NUMBER: AR5204, EXPIRATION DATE: MAR2022), FROM AN UNSPECIFIED DATE AT AN UNKNOWN FREQUENCY FOR STOMACH ACHE AND BLADDER CRAMPS. MEDICAL HISTORY INCLUDED HAY FEVER. CONCOMITANT MEDICATIONS INCLUDED GINKGO BILOBA, PANAX GINSENG (GINCOSAN) FROM (B)(6) 2020. THE PATIENT WANTED TO TEST THE THERMACARE LBH HEATWRAP AND APPLIED IT ON HER BACK WHERE IT WORKED WELL. AFTER A WHILE SHE TURNED THE PRODUCT TO THE FRONT AS SHE HAD STOMACH ACHE, BUT AS SHE REMOVED THE PRODUCT, SHE HAD A BURN BLISTER. DATE THE ISSUE OCCURRED OR WAS IDENTIFIED WAS DURING THE NIGHT, APPROXIMATELY 6 TO 14 HOURS AFTER APPLICATION. IT WAS FURTHER STATED THAT THE FEMALE PATIENT WAS SUFFERING FROM HAY FEVER AND HAD NO RELEVANT MEDIAL TREATMENT. GINCOSAN, HAD BEEN TAKEN FOR 4 WEEKS,1X DAILY, AS A CONCOMITANT MEDICATION. THERMACARE LBH HEATWRAP (LOT NR. AR5204 / EXP MAR2022) WAS USED FOR BLADDER CRAMPS. THERMACARE LBH HEATWRAP WAS WORN ON THE STOMACH FOR APPROXIMATIVELY 4 HOURS. THE PATIENT EXPLAINED SHE HAD PREVIOUSLY APPLIED A CHERRY STONE PILLOWS ON HER STOMACH AND WAS IN A SITTING POSITION. THE REACTION OCCURRED DURING THE NIGHT, APPROXIMATELY 6 TO 14 HOURS AFTER APPLICATION. A SMALL BURN BLISTER APPEARED AT A SINGLE LOCATION. IT WAS A CLASSIC WOUND HEALING, WITH NO CONSEQUENTIAL DAMAGE. THE PATIENT TREATED THE BURN BLISTER WITH MERFEN AND BEPANTHEN. SAMPLE AVAILABILITY OR PICTURES WAS NO. THE ACTION TAKEN IN RESPONSE TO THE EVENT WAS UNKNOWN. THE EVENT OUTCOME WAS RECOVERED. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP, SUMMARY OF INVESTIGATION: BATCH# AR5204. DATE OF MANUFACTURE: 04-04-2019 TO 04-09-2019. BATCH AR5204 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THEREMACARE BATCHES ARE PRODUCED AS INDIVIDUAL LOTS. THE DEVICE HISTORY RECORD (DHR), RESERVE SAMPLES, AND TRENDING WERE EVALUATED. NO QUALITY ISSUES WERE IDENTIFIED.CONCLUSION: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS THE WRAP CAUSED "BURN BLISTER AFTER USE ON THE STOMACH." THE CAUSE OF THE CONSUMER STATING THE WRAP CAUSED BURN BLISTER IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT A DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. CARE SHOULD BE TAKEN WHEN USING THE DEVICE, FOLLOWING ALL SAFETY AND USE INFORMATION AS PROVIDED WITH THE WRAP TO AVOID THE RISKS OF BURNS OR OTHER SKIN IRRITATIONS. OUR MANUFACTURING OPERATIONS EMPLOY QUALITY CONTROL PROCEDURES WHICH INCLUDE IN-PROCESS TESTING, THERMAL TESTING AND VISUAL INSPECTION, TO ENSURE THE QUALITY OF THE PRODUCT BEING PACKAGED. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF THE BATCH DEVICE HISTORY RECORD, IN PROCESS ATTRIBUTES AND VARIABLE QUALITY CHECKS OR, INSPECTION OF RETAINED SAMPLES. RETAINED SAMPLES MET THE PRODUCT DESCRIPTION AND THE PRODUCT IS WITHIN EXPIRATION DATE. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. LOT TREND ASSMT. & RATIONALE: AN EVALUATION OF THE COMPLAINT HISTORY CONFIRMS THAT THIS IS THE FIRST COMPLAINT FOR THE SUB CLASS ADVERSE EVENT/SERIOUS/UNKNOWN RECEIVED AT THE ALBANY SITE REQUIRING AN EVALUATION FOR THIS BATCH. ON THE BASIS OF THIS EVALUATION, A TREND DOES NOT EXIST FOR THIS LOT. EXPED TREND ASSMT. & RATIONALE: AN EVALUATION WAS MADE BY SEARCHING FOR POSSIBLE TREND FOR THIS SUBCLASS. EXPED TREND ACTIONS TAKEN: BASED ON THIS CITI CUSTOMIZABLE SEARCH FOR THE SUBCLASSES OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCTS THE DATA DID NOT SHOW AN INCREASE OVER TIME (36 MONTHS). THERE IS NOT A TREND IDENTIFIED FOR THE SUBCLASS OF ADVERSE EVENT/SERIOUS/UNKNOWN FOR LBH PRODUCT, REFER TO ATTACHMENT ADVERSE EVENT SERIOUS UNKNOWN LBH (B)(6) 2017 TO (B)(6) 2020. THERE WAS DEVIATION FROM (B)(4), COMPLAINT TRENDING GUIDELINES, EFFECTIVE (B)(6) 2020 IN WHICH THE EXPEDITE TRENDING OF COMPLAINT INVESTIGATIONS WAS TRENDED FOR A 24-MONTH PERIOD INSTEAD OF A 36-MONTH PERIOD. THIS INVESTIGATION WAS REOPENED TO CORRECT THE TRENDING. THE RESULTS DO NOT CHANGE THE ROOT CAUSE OF THE COMPLAINT. CORRECTIONS WILL BE COMPLETED IN (B)(4), ACTION ITEM PR-5283193. SITE SAMPLE STATUS: NOT RECEIVED. SEVERITY OF HARM WAS S3. FOLLOW-UP (15JUN2020, 22JUN2020, 22JUN2020 AND 22JUN2020): THIS CASE IS BEING SUBMITTED TO NOTIFY THAT THE INITIAL INFORMATION FOR THIS CASE WAS FIRST RECEIVED BY THE COMPANY ON 15JUN2020 AND NOT ON 19JUN2020 AS PREVIOUSLY REPORTED. DUE TO SAFETY DATABASE TECHNICAL LIMITATIONS, THE FIELD "INITIAL RECEIPT DATE" (I.E., COMPANY FIRST AWARENESS DATE) CAN NO LONGER BE MODIFIED. THE FOLLOWING CLARIFICATION WAS RECEIVED FROM ANGELINI: THE INITIAL RECEIPT DATE WAS (B)(6) 2020. THE RECEIPT DATE OF ALL FOLLOW-UP INFORMATION WAS 22JUN2020. NEW INFORMATION ALSO REPORTED FROM A CONTACTABLE CONSUMER BASED ON INFORMATION RECEIVED BY PFIZER FROM ANGELINI (REFERENCE # (B)(4) INCLUDED: DEVICE INFORMATION (INCLUDING SAMPLE AVAILABILITY, LOT NUMBER AND EXPIRATION DATE), MEDICAL HISTORY, CONCOMITANT MEDICATION AND EVENT DETAILS. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (05JUL2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATION RESULTS. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (09OCT2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDES UPDATED EXPEDITE TREND ASSESSMENT.
BURN BLISTER [BURNS SECOND DEGREE]. SHE TURNED THE PRODUCT TO THE FRONT AS SHE HAD STOMACH ACHE [DEVICE USE ISSUE]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP), FROM AN UNSPECIFIED DATE AT AN UNKNOWN FREQUENCY FOR STOMACH ACHE. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT WANTED TO TEST THE THERMACARE LBH HEATWRAP AND APPLIED IT ON HER BACK WHERE IT WORKED WELL. AFTER A WHILE SHE TURNED THE PRODUCT TO THE FRONT AS SHE HAD STOMACH ACHE, BUT AS SHE REMOVED THE PRODUCT, SHE HAD A BURN BLISTER. THE ACTION TAKEN IN RESPONSE TO THE EVENT WAS UNKNOWN. THE EVENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655561 | THERMACARE LOWER BACK & HIP | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE | AR5204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | GINCOSAN [DOSAGE FORM:]| GINCOSAN [DOSAGE FORM:]| GINCOSAN [DOSAGE FORM:] |