THERMACARE NECK, SHOULDER & WRIST
Report
- Report Number
- 1066015-2019-00066
- Event Type
- Injury
- Date Received
- March 14, 2019
- Date of Event
- February 26, 2019
- Report Date
- March 11, 2019
- Manufacturer
- PFIZER CONSUMER HEALTH CARE
- Product Code
- IMD
- PMA / PMN Number
- K953442
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
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 AN ADVERSE EVENT DUE TO BLISTERS. THE CAUSE OF THE ADVERSE EVENT IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT 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. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA 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.
THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). SAMPLE IS NOT AVAILABLE FOR EVALUATION BY THE SITE; COMPLAINT CANNOT BE CONFIRMED. AFTER A REVIEW OF THE SKIN CONTACT ADHESIVE LAMINATE (SCA) MATERIAL RECORDS FOR THE BATCH OF SCA USED IN THIS BATCH THE ROOT CAUSE OF WHY THE WRAPS WOULD NOT ADHERE TO THE BODY FOR USE IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. SCA LAMINATE PASSED ALL CRITERIA FOR RELEASE FOR USE IN MANUFACTURING. 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. NOTIFICATION TO SAFETY IS NOT REQUIRED. A WRAP NOT ADHERING HAS A SEVERITY OF S1, INCONVENIENT, ANNOYING BUT NO HARM, LOSS OR DETERIORATION OF FUNCTION PER RPT-74091, BRIDGING PFIZER HAL SEVERITY RANKING NUMBERS APPLIED IN THE THERMACARE HEAT WRAP RMP, EFFECTIVE 28 SEP 2018 SECTION 3.1.2.1.
EVENT VERBATIM [PREFERRED TERM] BURN BLISTER [BURNS SECOND DEGREE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) PZN: 00707372, LOT NUMBER: S91704, EXPIRATION DATE: JUN2020, 1 PER DAY, ON (B)(6) 2019 FOR NECK PAIN. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS UNKNOWN. THE PATIENT EXPERIENCED BURN BLISTER ON (B)(6) 2019. THE EVENT BURN BLISTER WAS REPORTED AS SERIOUS DUE TO MEDICALLY SIGNIFICANT BY THE REPORTER. THE LAST ADMINISTRATION WAS ON THE SAME DAY, (B)(6) 2019. UPON FOLLOW-UP RECEIVED ON (B)(6) 2019 FROM A CONTACTABLE PHARMACIST FROM LOCAL HEALTH AUTHORITY BFARM, IT WAS REPORTED THAT "A FEMALE PATIENT USED THERMACARE FOR NECK SHOULDER AND WRIST WITH LOT W21702 AND EXPERIENCED BURN BLISTERS ON (B)(6) 2019". THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS STOPPED ON (B)(6) 2019. THE EVENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (13MAR2019): NEW INFORMATION FROM LOCAL HEALTH AUTHORITY BFARM (CASE NUMBER: (B)(6)) INCLUDED: ADDITIONAL PRODUCT LOT NUMBER AND EVENT ONSET DATE. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT BURNS SECOND DEGREE AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT BURNS SECOND DEGREE AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
BURN BLISTER AT NECK [BURNS SECOND DEGREE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) PZN: 00707372, LOT NUMBER: S91704, EXPIRATION DATE: JUN2020, 1 PER DAY, ON (B)(6) 2019 FOR NECK PAIN. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS UNKNOWN. PRIOR TO THE REPORTED EVENT THERMACARE WAS USED AND WELL TOLERATED. THE PATIENT EXPERIENCED BURN BLISTER AT NECK ON (B)(6) 2019. THE EVENT BURN BLISTER WAS REPORTED AS SERIOUS DUE TO MEDICALLY SIGNIFICANT BY THE REPORTER. THE LAST ADMINISTRATION WAS ON THE SAME DAY, ON (B)(6) 2019. UPON FOLLOW-UP RECEIVED ON 13MAR2019 FROM A CONTACTABLE PHARMACIST FROM LOCAL HEALTH AUTHORITY BFARM, IT WAS REPORTED THAT "A FEMALE PATIENT USED THERMACARE FOR NECK SHOULDER AND WRIST WITH LOT: W21702 AND EXPERIENCED BURN BLISTERS ON (B)(6) 2019". UPON FOLLOW-UP ON 05APR2019, IT WAS REPORTED THAT THERMACARE WITH LOT NUMBER: W21702: "PLASTER DOES NOT STICK." ADDITIONAL INFORMATION REPORTED WAS SHE EXPERIENCED BURN BLISTER IN ALL AREAS OF "WARM CELL AREA" 11 X 1 PATTERN ON THE SKIN. NO SURGERY WAS NEEDED, AND IT WAS UNKNOWN IF TREATMENT WAS RECEIVED. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS STOPPED ON (B)(6) 2019. THE EVENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (13MAR2019): NEW INFORMATION FROM LOCAL HEALTH AUTHORITY BFARM (CASE NUMBER: (B)(4) INCLUDED: ADDITIONAL PRODUCT LOT NUMBER AND EVENT ONSET DATE. FOLLOW-UP (05APR2019): NEW INFORMATION RECEIVED FROM THE SAME CONTACTABLE PHARMACIST INCLUDES: PRODUCT INFORMATION, PAST DRUG HISTORY, AND EVENT DETAILS. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT BURNS SECOND DEGREE AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. NO FOLLOW-UP ATTEMPTS NEEDED. NO FURTHER INFORMATION EXPECTED., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT BURNS SECOND DEGREE AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
BURN BLISTER AT NECK [BURNS SECOND DEGREE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) PZN: 00707372, LOT NUMBER: S91704, EXPIRATION DATE: JUN2020, 1 PER DAY, ON (B)(6) 2019 FOR NECK PAIN. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS UNKNOWN. PRIOR TO THE REPORTED EVENT THERMACARE WAS USED AND WELL TOLERATED. THE PATIENT EXPERIENCED BURN BLISTER AT NECK ON (B)(6) 2019. THE EVENT BURN BLISTER WAS REPORTED AS SERIOUS DUE TO MEDICALLY SIGNIFICANT BY THE REPORTER. THE LAST ADMINISTRATION WAS ON THE SAME DAY, (B)(6) 2019. UPON FOLLOW-UP RECEIVED ON 13MAR2019 FROM A CONTACTABLE PHARMACIST FROM LOCAL HEALTH AUTHORITY BFARM, IT WAS REPORTED THAT "A FEMALE PATIENT USED THERMACARE FOR NECK SHOULDER AND WRIST WITH LOT W21702 AND EXPERIENCED BURN BLISTERS ON (B)(6) 2019". UPON FOLLOW-UP ON 05APR2019, IT WAS REPORTED THAT THERMACARE WITH LOT NUMBER W21702: "PLASTER DOES NOT STICK." ADDITIONAL INFORMATION REPORTED WAS SHE EXPERIENCED BURN BLISTER IN ALL AREAS OF "WARM CELL AREA" 11 X 1 PATTERN ON THE SKIN. NO SURGERY WAS NEEDED, AND IT WAS UNKNOWN IF TREATMENT WAS RECEIVED. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS STOPPED ON (B)(6) 2019. THE EVENT OUTCOME WAS UNKNOWN. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP: 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 AN ADVERSE EVENT DUE TO BLISTERS. THE CAUSE OF THE ADVERSE EVENT IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT 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. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA 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. FOLLOW-UP (13MAR2019): NEW INFORMATION FROM LOCAL HEALTH AUTHORITY BFARM (CASE NUMBER: (B)(4)) INCLUDED: ADDITIONAL PRODUCT LOT NUMBER AND EVENT ONSET DATE. FOLLOW-UP (05APR2019): NEW INFORMATION RECEIVED FROM THE SAME CONTACTABLE PHARMACIST INCLUDES: PRODUCT INFORMATION, PAST DRUG HISTORY, AND EVENT DETAILS. NO FOLLOW-UP ATTEMPTS NEEDED. NO FURTHER INFORMATION EXPECTED. FOLLOW UP (23APR2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: INVESTIGATIONAL RESULTS., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT "BURNS SECOND DEGREE" AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE REVIEW OF THE LOT/BATCH RECORDS DOES NOT SUGGEST A DEFECT OR QUALITY ISSUE RELATED TO THE MANUFACTURE OF THIS LOT. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED. PRODUCT EFFECT VARIES WITH EACH INDIVIDUAL. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME.
BURN BLISTER AT NECK [BURNS SECOND DEGREE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) PZN: 00707372, LOT NUMBER: S91704, EXPIRATION DATE: JUN2020, 1 PER DAY, ON (B)(6) 2019 FOR NECK PAIN. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS UNKNOWN. PRIOR TO THE REPORTED EVENT THERMACARE WAS USED AND WELL TOLERATED. THE PATIENT EXPERIENCED BURN BLISTER AT NECK ON (B)(6) 2019. THE EVENT BURN BLISTER WAS REPORTED AS SERIOUS DUE TO MEDICALLY SIGNIFICANT BY THE REPORTER. THE LAST ADMINISTRATION WAS ON THE SAME DAY, (B)(6) 2019. UPON FOLLOW-UP RECEIVED ON 13MAR2019 FROM A CONTACTABLE PHARMACIST FROM LOCAL HEALTH AUTHORITY BFARM, IT WAS REPORTED THAT "A FEMALE PATIENT USED THERMACARE FOR NECK SHOULDER AND WRIST WITH LOT W21702 AND EXPERIENCED BURN BLISTERS ON (B)(6) 2019". UPON FOLLOW-UP ON 05APR2019, IT WAS REPORTED THAT THERMACARE WITH LOT NUMBER W21702: "PLASTER DOES NOT STICK." ADDITIONAL INFORMATION REPORTED WAS SHE EXPERIENCED BURN BLISTER IN ALL AREAS OF "WARM CELL AREA" 11 X 1 PATTERN ON THE SKIN. NO SURGERY WAS NEEDED, AND IT WAS UNKNOWN IF TREATMENT WAS RECEIVED. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS STOPPED ON (B)(6) 2019. THE EVENT OUTCOME WAS UNKNOWN. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP: 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 AN ADVERSE EVENT DUE TO BLISTERS. THE CAUSE OF THE ADVERSE EVENT IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT 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. THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING PERSPECTIVE. NO QUALITY ISSUES WERE IDENTIFIED UPON THIS REVIEW OF BATCH RECORDS, RELEASE TESTING DATA 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. ADDITIONAL INVESTIGATION SUMMARY REPORTS THAT: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). SAMPLE IS NOT AVAILABLE FOR EVALUATION BY THE SITE; COMPLAINT CANNOT BE CONFIRMED. AFTER A REVIEW OF THE SKIN CONTACT ADHESIVE LAMINATE (SCA) MATERIAL RECORDS FOR THE BATCH OF SCA USED IN THIS BATCH THE ROOT CAUSE OF WHY THE WRAPS WOULD NOT ADHERE TO THE BODY FOR USE IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. SCA LAMINATE PASSED ALL CRITERIA FOR RELEASE FOR USE IN MANUFACTURING. 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. NOTIFICATION TO SAFETY IS NOT REQUIRED. A WRAP NOT ADHERING HAS A SEVERITY OF S1, INCONVENIENT, ANNOYING BUT NO HARM, LOSS OR DETERIORATION OF FUNCTION PER RPT-74091, BRIDGING PFIZER HAL SEVERITY RANKING NUMBERS APPLIED IN THE THERMACARE HEAT WRAP RMP, EFFECTIVE 28 SEP 2018 SECTION 3.1.2.1. FOLLOW-UP (13MAR2019): NEW INFORMATION FROM LOCAL HEALTH AUTHORITY BFARM (CASE NUMBER: 02961/19) INCLUDED: ADDITIONAL PRODUCT LOT NUMBER AND EVENT ONSET DATE. FOLLOW-UP (05APR2019): NEW INFORMATION RECEIVED FROM THE SAME CONTACTABLE PHARMACIST INCLUDES: PRODUCT INFORMATION, PAST DRUG HISTORY, AND EVENT DETAILS. NO FOLLOW-UP ATTEMPTS NEEDED. NO FURTHER INFORMATION EXPECTED. FOLLOW UP (23APR2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: INVESTIGATIONAL RESULTS. FOLLOW-UP (02MAY2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: ADDITIONAL INVESTIGATION RESULTS : NO FOLLOW-UP ATTEMPTS NEEDED. NO FURTHER INFORMATION EXPECTED., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT "BURNS SECOND DEGREE" AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE REVIEW OF THE LOT/BATCH RECORDS DOES NOT SUGGEST A DEFECT OR QUALITY ISSUE RELATED TO THE MANUFACTURE OF THIS LOT. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED. PRODUCT EFFECT VARIES WITH EACH INDIVIDUAL. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME.
EVENT VERBATIM [PREFERRED TERM] BURN BLISTER [BURNS SECOND DEGREE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) PZN: 00707372, LOT NUMBER: S91704, EXPIRATION DATE: JUN2020, 1 PER DAY, ON (B)(6) 2019 FOR NECK PAIN. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS UNKNOWN. THE PATIENT EXPERIENCED BURN BLISTER ON (B)(6) 2019. THE EVENT BURN BLISTER WAS REPORTED AS SERIOUS DUE TO MEDICALLY SIGNIFICANT BY THE REPORTER. THE LAST ADMINISTRATION WAS ON THE SAME DAY, (B)(6) 2019. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS STOPPED ON (B)(6) 2019. THE EVENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT BURNS SECOND DEGREE AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT BURNS SECOND DEGREE AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENT IS MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212801 | THERMACARE NECK, SHOULDER & WRIST | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE | S91704; W21702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |