THERMACARE LOWER BACK & HIP
Report
- Report Number
- 1066015-2019-00067
- Event Type
- Injury
- Date Received
- March 15, 2019
- Date of Event
- February 25, 2019
- Report Date
- March 11, 2019
- Manufacturer
- PFIZER CONSUMER HEALTH CARE
- Product Code
- IMD
- PMA / PMN Number
- K953442
- Adverse Event
- 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.
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 LOWER BACK & HIP), DEVICE LOT NUMBER T81948, EXPIRATION DATE JAN2021, PZN: 00707366, FROM 25FEB2019 TO 25FEB2019 AT ONE HEATWRAP ONCE DAILY FOR BACK PAIN. THERE WERE NO CONCOMITANT DRUGS, NO RELEVANT MEDICAL HISTORY, OR LABORATORY TESTS. PREVIOUSLY THE PATIENT USED THERMACARE AND IT WAS WELL-TOLERATED. THE PATIENT USED THERMACARE LOWER BACK & HIP AND EXPERIENCED BURN BLISTER ON 25FEB2019. THE EVENT WAS REPORTED AS MEDICALLY SIGNIFICANT. THE PHARMACIST DESCRIBED THE BURN BLISTER DEVELOPMENT WAS ACCORDING TO PATTERN OF WARM CELLS, BURNING SECOND DEGREE. THERE WAS NO SURGERY, AND IT WAS UNKNOWN IF TREATMENT WAS NECESSARY OR PRODUCTS WERE TAKEN AT THE TIME OF EVENT. IT WAS UNKNOWN IF THE PATIENT WOULD EXPECT LONG-TERM DAMAGE ON HER SKIN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP AND THE OUTCOME OF THE EVENT WERE 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 RECEIVED FROM A CONTACTABLE PHARMACIST FROM LOCAL HEALTH AUTHORITY BFARM (REGULATORY AUTHORITY NUMBER: 02929/19) INCLUDED: EVENT ONSET DATE. FOLLOW-UP (05APR2019): NEW INFORMATION RECEIVED FROM A CONTACTABLE PHARMACIST INCLUDES: UPDATED SUSPECT PRODUCT ADMINISTRATION DATES, PAST PRODUCT HISTORY, AND UPDATED EVENT DESCRIPTION. FOLLOW-UP (04JUN2019): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: INVESTIGATIONAL RESULTS. VERY 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. 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 LOWER BACK & HIP), DEVICE LOT NUMBER T81948, EXPIRATION DATE JAN2021, PZN: 00707366, FROM (B)(6) 2019 TO (B)(6) 2019 AT ONE HEATWRAP ONCE DAILY FOR BACK PAIN. THERE WERE NO CONCOMITANT DRUGS, NO RELEVANT MEDICAL HISTORY, OR LABORATORY TESTS. PREVIOUSLY THE PATIENT USED THERMACARE AND IT WAS WELL-TOLERATED. THE PATIENT USED THERMACARE LOWER BACK & HIP AND EXPERIENCED BURN BLISTER ON 25FEB2019. THE EVENT WAS REPORTED AS MEDICALLY SIGNIFICANT. THE PHARMACIST DESCRIBED THE BURN BLISTER DEVELOPMENT WAS ACCORDING TO PATTERN OF WARM CELLS, BURNING SECOND DEGREE. THERE WAS NO SURGERY, AND IT WAS UNKNOWN IF TREATMENT WAS NECESSARY OR PRODUCTS WERE TAKEN AT THE TIME OF EVENT. IT WAS UNKNOWN IF THE PATIENT WOULD BE EXPECT LONG-TERM DAMAGE ON HER SKIN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP AND THE OUTCOME OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (13MAR2019): NEW INFORMATION RECEIVED FROM A CONTACTABLE PHARMACIST FROM LOCAL HEALTH AUTHORITY BFARM (REGULATORY AUTHORITY NUMBER: 02929/19) INCLUDED: EVENT ONSET DATE. FOLLOW-UP (05APR2019): NEW INFORMATION RECEIVED FROM A CONTACTABLE PHARMACIST INCLUDES: UPDATED SUSPECT PRODUCT ADMINISTRATION DATES, PAST PRODUCT HISTORY, AND UPDATED EVENT DESCRIPTION. 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.
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 LOWER BACK & HIP), DEVICE LOT NUMBER T81948, EXPIRATION DATE JAN2021, PZN: 00707366, FROM 02MAR2019 TO 02MAR2019 AT ONE HEATWRAP ONCE DAILY FOR BACK PAIN. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT PREVIOUSLY USED THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) FROM (B)(6) 2019 AT 1 PER DAY FOR NECK PAIN AND EXPERIENCED BURN BLISTER ON (B)(6) 2019. THE PATIENT USED THERMACARE LOWER BACK & HIP AND EXPERIENCED BURN BLISTER ON (B)(6) 2019. THE EVENT WAS REPORTED AS MEDICALLY SIGNIFICANT. UPON FOLLOW-UP RECEIVED ON 13MAR2019 FROM A CONTACTABLE PHARMACIST FROM LOCAL HEALTH AUTHORITY BFARM, IT WAS REPORTED THAT THE PATIENT USED THERMACARE FOR THE BACK WITH LOT T81948 AND EXPERIENCED BURN BLISTERS ON (B)(6) 2019. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (13MAR2019): NEW INFORMATION RECEIVED FROM A CONTACTABLE PHARMACIST FROM LOCAL HEALTH AUTHORITY BFARM (REGULATORY AUTHORITY NUMBER: 02929/19) INCLUDED: 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 [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 LOWER BACK & HIP), DEVICE LOT NUMBER T81948, EXPIRATION DATE JAN2021, PZN: 00707366, FROM (B)(6) 2019 AT ONE HEATWRAP ONCE DAILY FOR BACK PAIN. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT PREVIOUSLY USED THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) FROM (B)(6) 2019 AT 1 PER DAY FOR NECK PAIN AND EXPERIENCED BURN BLISTER ON (B)(6) 2019. THE PATIENT USED THERMACARE LOWER BACK & HIP AND EXPERIENCED BURN BLISTER ON (B)(6) 2019. THE EVENT WAS REPORTED AS MEDICALLY SIGNIFICANT. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS UNKNOWN. THE OUTCOME OF THE EVENT 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 217740 | THERMACARE LOWER BACK & HIP | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE | T81948 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 0 | Other| R | |||
| 1 | Other| O| R| R |