THERMACARE FUER FLEXIBLE ANWENDUNG
Report
- Report Number
- 1066015-2018-00054
- Event Type
- Injury
- Date Received
- April 16, 2018
- Date of Event
- March 28, 2018
- Report Date
- April 11, 2018
- 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). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS WRAPS WERE "TOO HOT". THE CAUSE OF THE WRAPS BEING TOO HOT IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. 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.
EVENT VERBATIM [PREFERRED TERM] BURN BLISTER (3 BURN BLISTERS, 2 SMALL, 1 LARGE AS A COIN)/ THE LARGE BURN BLISTER BURST AND WAS WEEPING/SCABS [BURNS SECOND DEGREE] , THE PATCH GOT VERY HOT [DEVICE ISSUE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA PFIZER CONSUMER HEALTH CARE. A 65-YEAR-OLD FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO USE THERMACARE HEATWRAP (THERMACARE FUER FLEXIBLE ANWENDUNG) ON 28MAR2018 CUTANEOUS FOR NECK TIGHTNESS THE LOT# WAS NOT A 100% KNOWN, SUPPOSEDLY N61530, EXPIRY DATE DEC2019. THE PATIENT'S MEDICAL HISTORY INCLUDED ONGOING OSTEOPOROSIS, ONGOING ROSACEA, NICOTINE USE (10-15 CIGARETTES PER DAY), AND HOSPITAL STAY DUE TO A FALL IN 2018. CONCOMITANT MEDICATIONS INCLUDED ALENDRONIC ACID AT 70MG ONCE A WEEK SINCE 07MAR2018 FOR OSTEOPOROSIS. THE PATIENT PREVIOUSLY SHORT-TERM USED OXYCODONE DUE TO FALL AND HAS ALREADY BEEN USED THERMACARE PRODUCTS FOR YEARS AND TOLERATED/WITHOUT PROBLEMS BEFORE. THE PATIENT EXPERIENCED BURN BLISTER ON 28MAR2018. THE PATCH GOT VERY HOT AND WAS REMOVED AFTER A FEW MINUTES. 10-15 MIN AFTER ADMINISTRATION THERMACARE HAS BEEN REMOVED DUE TO SEVERE DEVELOPMENT OF HEAT, 3 BURN BLISTERS (2 SMALL, 1 AS LARGE AS A COIN). THE LARGE BURN BLISTER BURST AND WAS WEEPING. ONE COIN-SIZED WEEPING BURST BLISTER. COVERED WITH STERILE PLASTER, NOW ALMOST COMPLETELY HEALED. 4 WEEKS PRIOR TO THIS EVENT HOSPITAL STAY DUE TO A FALL. SHORT-TERM USE OF OXYCODONE. THREE WEEKS PRIOR TO THIS EVENT START OF OSTEOPOROSIS THERAPY. THIS THERMACARE HEATWRAP WAS THE FIRST USED FOLLOWING HOSPITAL STAY AND START OF ALENDRONIC ACID THERAPY. THE EVENT DID NOT RESOLVE FOLLOWING WITHDRAWAL OF THE PRODUCT. THERE WERE STILL SCABS. THE EVENT DID NOT RECUR FOLLOWING REUSE OF THE PRODUCT. ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEAT WRAP WAS TEMPORARILY WITHDRAWN IN 2018. NEITHER SURGICAL INTERVENTION, NOR TREATMENT WAS NECESSARY, ONLY PLASTER AS PROTECTION. NO PERMANENT DAMAGE WAS EXPECTED. THE EVENT WAS ASSESSED SERIOUS (MEDICALLY SIGNIFICANT) BY THE PHARMACIST. THE OUTCOME OF THE EVENTS WAS NOT RESOLVED. AFFECTED HEATWRAP WAS AVAILABLE (WITHOUT EXTERNAL PACKAGE). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (23APR2018): NEW INFORMATION RECEIVED FROM THE SAME PHARMACY INCLUDED: AGE, DEVICE START DATE, ROUTE, INDICATION, ACTION TAKEN, LOT NUMBER, EXPIRATION DATE, MEDICAL HISTORY, PAST DRUG, CONCOMITANT MEDICATION, MORE EVENT DETAIL, EVENT OUTCOME. THE EVENT WAS ASSESSED SERIOUS (MEDICALLY SIGNIFICANT) BY THE PHARMACIST. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF BURNS SECOND DEGREE AND DEVICE ISSUE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY 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 BURNS SECOND DEGREE AND DEVICE ISSUE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY 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] BURN BLISTER (3 BURN BLISTERS, 2 SMALL, 1 LARGE AS A COIN)/ THE LARGE BURN BLISTER BURST AND WAS WEEPING/SCABS [BURNS SECOND DEGREE] , THE PATCH GOT VERY HOT [DEVICE ISSUE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA PFIZER CONSUMER HEALTH CARE. A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO USE THERMACARE HEATWRAP (THERMACARE FUER FLEXIBLE ANWENDUNG) ON (B)(6) 2018 CUTANEOUS FOR NECK TIGHTNESS THE LOT# WAS NOT A 100% KNOWN, SUPPOSEDLY N61530, EXPIRY DATE DEC2019. THE PATIENT'S MEDICAL HISTORY INCLUDED ONGOING OSTEOPOROSIS, ONGOING ROSACEA, NICOTINE USE (10-15 CIGARETTES PER DAY), AND HOSPITAL STAY DUE TO A FALL IN 2018. CONCOMITANT MEDICATIONS INCLUDED ALENDRONIC ACID AT 70MG ONCE A WEEK SINCE (B)(6) 2018 FOR OSTEOPOROSIS. THE PATIENT PREVIOUSLY SHORT-TERM USED OXYCODONE DUE TO FALL AND HAS ALREADY BEEN USED THERMACARE PRODUCTS FOR YEARS AND TOLERATED/WITHOUT PROBLEMS BEFORE. THE PATIENT EXPERIENCED BURN BLISTER ON (B)(6) 2018. THE PATCH GOT VERY HOT AND WAS REMOVED AFTER A FEW MINUTES. 10-15 MIN AFTER ADMINISTRATION THERMACARE HAS BEEN REMOVED DUE TO SEVERE DEVELOPMENT OF HEAT, 3 BURN BLISTERS (2 SMALL, 1 AS LARGE AS A COIN). THE LARGE BURN BLISTER BURST AND WAS WEEPING. ONE COIN-SIZED WEEPING BURST BLISTER. COVERED WITH STERILE PLASTER, NOW ALMOST COMPLETELY HEALED. 4 WEEKS PRIOR TO THIS EVENT HOSPITAL STAY DUE TO A FALL. SHORT-TERM USE OF OXYCODONE. THREE WEEKS PRIOR TO THIS EVENT START OF OSTEOPOROSIS THERAPY. THIS THERMACARE HEATWRAP WAS THE FIRST USED FOLLOWING HOSPITAL STAY AND START OF ALENDRONIC ACID THERAPY. THE EVENT DID NOT RESOLVE FOLLOWING WITHDRAWAL OF THE PRODUCT. THERE WERE STILL SCABS. THE EVENT DID NOT RECUR FOLLOWING REUSE OF THE PRODUCT. ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEAT WRAP WAS TEMPORARILY WITHDRAWN IN 2018. NEITHER SURGICAL INTERVENTION, NOR TREATMENT WAS NECESSARY, ONLY PLASTER AS PROTECTION. NO PERMANENT DAMAGE WAS EXPECTED. THE EVENT WAS ASSESSED SERIOUS (MEDICALLY SIGNIFICANT) BY THE PHARMACIST. THE OUTCOME OF THE EVENTS WAS NOT RESOLVED. AFFECTED HEATWRAP WAS AVAILABLE (WITHOUT EXTERNAL PACKAGE). ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED). AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER REPORTS WRAPS WERE "TOO HOT". THE CAUSE OF THE WRAPS BEING TOO HOT IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (23APR2018): NEW INFORMATION RECEIVED FROM THE SAME PHARMACY INCLUDED: AGE, DEVICE START DATE, ROUTE, INDICATION, ACTION TAKEN, LOT NUMBER, EXPIRATION DATE, MEDICAL HISTORY, PAST DRUG, CONCOMITANT MEDICATION, MORE EVENT DETAIL, EVENT OUTCOME. THE EVENT WAS ASSESSED SERIOUS (MEDICALLY SIGNIFICANT) BY THE PHARMACIST. FOLLOW-UP (27APR2018): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDED: INVESTIGATIONAL RESULTS. NO FOLLOW-UP ATTEMPTS NEEDED. NO FURTHER INFORMATION EXPECTED. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENTS OF BURNS SECOND DEGREE AND DEVICE ISSUE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY 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 BURNS SECOND DEGREE AND DEVICE ISSUE AS DESCRIBED ARE CONSIDERED SERIOUS BODILY INJURY 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] BURN BLISTER [BURNS SECOND DEGREE] , THE PATCH GOT VERY HOT [DEVICE ISSUE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA PFIZER CONSUMER HEALTH CARE. A FEMALE PATIENT IN THE BEGINNING OF HER (B)(6) OF AN UNSPECIFIED ETHNICITY STARTED TO USE THERMACARE HEAT WRAP (THERMACARE FUER FLEXIBLE ANWENDUNG) (DEVICE LOT NUMBER AND EXPIRATION DATE WERE NOT AVAILABLE) ON AN UNSPECIFIED DATE IN 2018 ONE TIME "IN THE CW 13 OR 14" FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN 2018, THE PATIENT EXPERIENCED A BURN BLISTER. THE PATCH GOT VERY HOT AND WAS REMOVED AFTER A FEW MINUTES. ACTION TAKEN IN RESPONSE TO THE EVENTS FOR THERMACARE HEAT WRAP WAS UNKNOWN. CLINICAL OUTCOME OF THE EVENTS 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 EVENTS OF BURNS SECOND DEGREE 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 BURNS SECOND DEGREE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274657 | THERMACARE FUER FLEXIBLE ANWENDUNG | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE | N61530 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other| R | ALENDRONIC ACID| ALENDRONIC ACID |