THERMACARE LOWER BACK & HIP
Report
- Report Number
- 1066015-2017-00183
- Event Type
- Injury
- Date Received
- December 21, 2017
- Date of Event
- December 6, 2017
- Report Date
- December 15, 2017
- 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). COMPLAINT STEMS FROM WRAP BECOMING "EXTREMELY HOT". AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA PER SPEC-23451, EFFECTIVE: 28NOV2016. THE CAUSE OF THE WRAP BECOMING "EXTREMELY HOT" IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. 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] APPLIED THE PRODUCT AND COOKED AT THE SAME TIME/AFTER USE, SHE NOTICED BURN BLISTERS [BURNS SECOND DEGREE] , SCAR [SCAR] , THE HEATWRAP GOT EXTREMELY HOT [DEVICE ISSUE]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST. A (B)(6) YEAR-OLD FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (DEVICE LOT NUMBER S1666 101116, EXPIRATION DATE: DEC2019) FROM AN UNSPECIFIED DATE FOR BACK PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED SMOKER (15/DAY) AND ALCOHOL USE (GLASS OF WINE OR BEER). CONCOMITANT MEDICATIONS WERE NOT REPORTED. PAST PRODUCT HISTORY INCLUDED THERMACARE HEATWRAPS (THERMACARE HEATWRAPS) FROM AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION WITH NO ADVERSE EFFECT. THE PATIENT HAD USED THERMACARE HEATWRAPS OFTEN AND NEVER HAD ANY PROBLEMS WITH THEM. ON (B)(6) 2017, THE PATIENT APPLIED A THERMACARE HEATWRAP (FOR THE BACK) OVER A T-SHIRT, AND AT THE SAME TIME, SHE WAS COOKING. AFTER APPROXIMATELY 8 HOURS, WHEN SHE WAS PREPARING FOOD WITH THE "INDUCTION HOB", THE HEATWRAP GOT EXTREMELY HOT, SO THAT EVEN BY HAND IT FELT HOT. SHE EXPERIENCED BURN BLISTERS WITH SEQUEL (SCAR). SHE STATED "ON THE CHAMBERS WITH THE IRON FILINGS ADHERED SKIN RESIDUE OF MY BACK. THE IRON FILINGS PROBABLY REACTED WITH THE MAGNETIC FIELD OF THE INDUCTION HOB". ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. CLINICAL OUTCOME OF THE EVENT BURN BLISTER WAS RESOLVED WITH SEQUEL ON (B)(6) 2017. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (29JAN2018): NEW INFORMATION RECEIVED FROM THE CONTACTABLE CONSUMER INCLUDES: PATIENT DETAILS, PATIENT MEDICAL HISTORY, PAST MEDICAL HISTORY, SUSPECT PRODUCT INDICATION, SUSPECT PRODUCT LOT NUMBER AND EXPIRATION DATE, REACTION DATA (ADDITIONAL EVENT SCAR), EVENT ONSET DATE AND EVENT OUTCOME. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE EVENTS OF BURN BLISTERS, SCAR, AND DEVICE ISSUE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF BURN BLISTERS, SCAR, AND DEVICE ISSUE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE MEDICALLY ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE.
EVENT VERBATIM [PREFERRED TERM] APPLIED THE PRODUCT AND COOKED AT THE SAME TIME/AFTER USE, SHE NOTICED BURN BLISTERS [BURNS SECOND DEGREE] , SCAR [SCAR] , THE HEATWRAP GOT EXTREMELY HOT [DEVICE ISSUE], . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST. A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (DEVICE LOT NUMBER S1666 101116, EXPIRATION DATE: DEC2019) FROM AN UNSPECIFIED DATE FOR BACK PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED SMOKER (15/DAY) AND ALCOHOL USE (GLASS OF WINE OR BEER). CONCOMITANT MEDICATIONS WERE NOT REPORTED. PAST PRODUCT HISTORY INCLUDED THERMACARE HEATWRAPS (THERMACARE HEATWRAPS) FROM AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION WITH NO ADVERSE EFFECT. THE PATIENT HAD USED THERMACARE HEATWRAPS OFTEN AND NEVER HAD ANY PROBLEMS WITH THEM. ON (B)(6) 2017, THE PATIENT APPLIED A THERMACARE HEATWRAP (FOR THE BACK) OVER A T-SHIRT, AND AT THE SAME TIME, SHE WAS COOKING. AFTER APPROXIMATELY 8 HOURS, WHEN SHE WAS PREPARING FOOD WITH THE "INDUCTION HOB", THE HEATWRAP GOT EXTREMELY HOT, SO THAT EVEN BY HAND IT FELT HOT. SHE EXPERIENCED BURN BLISTERS WITH SEQUEL (SCAR). SHE STATED "ON THE CHAMBERS WITH THE IRON FILINGS ADHERED SKIN RESIDUE OF MY BACK. THE IRON FILINGS PROBABLY REACTED WITH THE MAGNETIC FIELD OF THE INDUCTION HOB". ACTION TAKEN WITH THE SUSPECT PRODUCT WAS UNKNOWN. CLINICAL OUTCOME OF THE EVENT BURN BLISTER WAS RESOLVED WITH SEQUEL ON (B)(6) 2017. AS OF 05FEB2018, THE PRODUCT QUALITY COMPLAINT (PQC) GROUP INVESTIGATION RESULTS STATED THAT THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED). COMPLAINT STEMS FROM WRAP BECOMING "EXTREMELY HOT". AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA PER SPEC-23451, EFFECTIVE: 28NOV2016. THE CAUSE OF THE WRAP BECOMING "EXTREMELY HOT" IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. 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 INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (29JAN2018): NEW INFORMATION RECEIVED FROM THE CONTACTABLE CONSUMER INCLUDES: PATIENT DETAILS, PATIENT MEDICAL HISTORY, PAST MEDICAL HISTORY, SUSPECT PRODUCT INDICATION, SUSPECT PRODUCT LOT NUMBER AND EXPIRATION DATE, REACTION DATA (ADDITIONAL EVENT SCAR), EVENT ONSET DATE AND EVENT OUTCOME. FOLLOW-UP (05FEB2018): NEW INFORMATION REPORTED FROM THE PQC GROUP INCLUDES: PRODUCT INVESTIGATION SUMMARY RESULTS. FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF BURN BLISTERS, SCAR, AND DEVICE ISSUE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE 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. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME., COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF BURN BLISTERS, SCAR, AND DEVICE ISSUE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE. THE EVENTS ARE 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. NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED. NO REMEDIAL ACTION/CORRECTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION IS SUGGESTED AT THIS TIME.
EVENT VERBATIM [PREFERRED TERM] APPLIED THE PRODUCT AND COOKED AT THE SAME TIME/AFTER USE, SHE NOTICED BURN BLISTERS [BURNS SECOND DEGREE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST. A FEMALE PATIENT OF AN UNSPECIFIED AGE AND ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) FROM AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT HAD USED THERMACARE HEATWRAPS OFTEN AND NEVER HAD ANY PROBLEMS WITH THEM. RECENTLY, SHE HAD APPLIED A THERMACARE HEATWRAP (FOR THE BACK), AND AT THE SAME TIME, SHE WAS COOKING. AFTER USE, SHE NOTICED BURN BLISTERS. SHE WAS INQUIRING WHETHER THE BURN BLISTERS COULD HAVE SOMETHING TO DO WITH THE INDUCTION FROM HER STOVE. THE ACTION TAKEN AND EVENT OUTCOME WERE 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 OF "BURN BLISTERS" AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY 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 OF "BURN BLISTERS" AS DESCRIBED IS CONSIDERED SERIOUS BODILY INJURY 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 |
|---|---|---|---|---|---|---|---|
| 918676 | THERMACARE LOWER BACK & HIP | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE | S1666 101116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |