THERMACARE LOWER BACK & HIP
Report
- Report Number
- 1066015-2016-00003
- Event Type
- Injury
- Date Received
- January 22, 2016
- Date of Event
- September 21, 2015
- Report Date
- November 11, 2015
- Manufacturer
- PFIZER CONSUMER HEALTH CARE
- Product Code
- IMD
- PMA / PMN Number
- K953442
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHARMACIST
Narratives
SUMMARY OF INVESTIGATIONS: BATCH L44146 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THERMACARE 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 REPORTED WRAP CAUSED ¿SEVERE SKIN IRRITATION AND BURN BLISTERS ON THREE SITES OF THE BACK.¿ THE CAUSE OF THE CONSUMER REPORTING THE WRAP CAUSED ¿SEVERE SKIN IRRITATION AND BURN BLISTERS ON THREE SITES OF THE BACK¿ 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. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT.
EVENT VERBATIM [PREFERRED TERM]. BURN SECOND DEGREE WITH BLISTERS/SEVERE SKIN IRRITATION WITH BLISTER [BURNS SECOND DEGREE], , NARRATIVE: THIS IS A SPONTANEOUS REPORT RECEIVED FROM THE GERMAN HEALTH AUTHORITY (BUNDESINSTITUT FUER ARZNEIMITTEL UND MEDIZINPRODUKTE, BFARM). REGULATORY AUTHORITY REPORT NUMBER (B)(4). A CONTACTABLE PHARMACIST REPORTED A 50-YEAR-OLD FEMALE PATIENT (NO PREGNANT) STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (LOT #: L44146, EXPIRATION DATE: MAR2018) ON AN UNSPECIFIED DATE FOR BACK COMPLAINTS. THE PATIENT'S MEDICAL HISTORY INCLUDED STRUMECTOMY. CONCOMITANT MEDICATIONS INCLUDED LEVOTHYROXINE SODIUM (L-THYROXIN) TABLETS FROM AN UNSPECIFIED DATE AND ONGOING. ON (B)(6) 2015, THE PATIENT USED THE PRODUCT FOR 8 HOURS AND EXPERIENCED SEVERE SKIN IRRITATION, BURN BLISTERS AT 3 SITES ON THE BACK, ONE OF THE BLISTERS DIRECTLY OPENED, BURN SECOND DEGREE. THE TREATMENT FOR THE EVENTS INCLUDED COVERING OF BURN SITE (SECOND DEGREE) TILL HEALING UP AND REGULAR DISINFECTION. ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN ON AN UNKNOWN DATE. CLINICAL OUTCOME OF THE EVENTS WAS RECOVERED APPROXIMATELY ON (B)(6) 2015. THE PHARMACIST ASSESSMENT IS THE EVENT BURN SECOND DEGREE IS MEDICALLY SIGNIFICANT AND RELATED TO THE PRODUCT. ACCORDING TO PRODUCT QUALITY COMPLAINT: SITE HAD NOT RECEIVED SAMPLE. SUMMARY OF INVESTIGATIONS: BATCH L44146 IS THE ONLY BATCH WITHIN THE SCOPE OF THIS INVESTIGATION. THERMACARE 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 REPORTED WRAP CAUSED "SEVERE SKIN IRRITATION AND BURN BLISTERS ON THREE SITES OF THE BACK." THE CAUSE OF THE CONSUMER REPORTING THE WRAP CAUSED "SEVERE SKIN IRRITATION AND BURN BLISTERS ON THREE SITES OF THE BACK" 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. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT. FOLLOW UP (04JAN2016): NEW INFORMATION RECEIVED FROM PHARMACIST INCLUDED: PATIENT AGE, MEDICAL HISTORY, CONCOMITANT MEDICATION, SUSPECT PRODUCT UPDATED TO THERMACARE LOWER BACK & HIP, NEW EVENT (BURN SECOND DEGREE), EVENT TREATMENT AND OUTCOME, AND REPORTER ASSESSMENT. FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (17FEB2016): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: PRODUCT LOT NUMBER AND EXPIRATION DATE ADDED. FOLLOW-UP (08JUN2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT INCLUDED INVESTIGATION RESULTS.
CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT RECEIVED FROM THE (B)(4). REGULATORY AUTHORITY REPORT NUMBER (B)(4). A CONTACTABLE PHARMACIST REPORTED A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (LOT #: L44146, EXPIRATION DATE: MAR2018) ON AN UNSPECIFIED DATE FOR BACK COMPLAINTS. THE PATIENT'S MEDICAL HISTORY INCLUDED STRUMECTOMY. CONCOMITANT MEDICATIONS INCLUDED LEVOTHYROXINE SODIUM (L-THYROXIN) TABLETS, 150UG ONCE DAILY. ON (B)(6) 2015, THE PATIENT USED THE PRODUCT FOR 8 HOURS AND EXPERIENCED SEVERE SKIN IRRITATION, BURN BLISTERS AT 3 SITES ON THE BACK, ONE OF THE BLISTERS DIRECTLY OPENED, BURN SECOND DEGREE. THE TREATMENT FOR THE EVENTS INCLUDED COVERING OF BURN SITE (SECOND DEGREE) TILL HEALING UP AND REGULAR DISINFECTION. ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN ON AN UNKNOWN DATE. CLINICAL OUTCOME OF THE EVENTS WAS RECOVERED APPROXIMATELY ON (B)(6) 2015. THE PHARMACIST ASSESSMENT IS THE EVENT BURN SECOND DEGREE IS MEDICALLY SIGNIFICANT AND RELATED TO THE PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW UP (04JAN2016): NEW INFORMATION RECEIVED FROM PHARMACIST INCLUDED: PATIENT AGE, MEDICAL HISTORY, CONCOMITANT MEDICATION, SUSPECT PRODUCT UPDATED TO THERMACARE LOWER BACK & HIP, NEW EVENT (BURN SECOND DEGREE), EVENT TREATMENT AND OUTCOME, AND REPORTER ASSESSMENT. FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (17FEB2016): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: PRODUCT LOT NUMBER AND EXPIRATION DATE ADDED. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN SECOND DEGREE WITH BLISTER" AS DESCRIBED IN THIS CASE IS CONSIDERED A SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, AND THE EVENT IS ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE EVENT OF SKIN IRRITATION IS NON-SERIOUS AND ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THIS CASE MEETS FOLLOW-UP 10-DAY EU AND 30-DAY FDA REPORTABILITY. CASE COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN SECOND DEGREE WITH BLISTER" AS DESCRIBED IN THIS CASE IS CONSIDERED A SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, AND THE EVENT IS ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THE EVENT OF SKIN IRRITATION IS NON-SERIOUS AND ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THIS CASE MEETS FOLLOW-UP 10-DAY EU AND 30-DAY FDA REPORTABILITY.
BURN SECOND DEGREE WITH BLISTERS [BURNS SECOND DEGREE]. SEVERE SKIN IRRITATION WITH BLISTER [SKIN IRRITATION]. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT RECEIVED FROM THE (B)(6 )REGULATORY AUTHORITY REPORT NUMBER (B)(4). A CONTACTABLE PHARMACIST REPORTED A (B)(6)-YEAR-OLD FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) (LOT #: L44146, EXPIRATION DATE: MAR2018) ON AN UNSPECIFIED DATE FOR BACK COMPLAINTS. THE PATIENT'S MEDICAL HISTORY INCLUDED STRUMECTOMY. CONCOMITANT MEDICATIONS INCLUDED LEVOTHYROXINE SODIUM (L-THYROXIN) TABLETS, 150UG ONCE DAILY. ON (B)(6) 2015, THE PATIENT USED THE PRODUCT FOR 8 HOURS AND EXPERIENCED SEVERE SKIN IRRITATION, BURN BLISTERS AT 3 SITES ON THE BACK, ONE OF THE BLISTERS DIRECTLY OPENED, BURN SECOND DEGREE. THE TREATMENT FOR THE EVENTS INCLUDED COVERING OF BURN SITE (SECOND DEGREE) TILL HEALING UP AND REGULAR DISINFECTION. ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN ON AN UNKNOWN DATE. CLINICAL OUTCOME OF THE EVENTS WAS RECOVERED APPROXIMATELY ON (B)(6) 2015. THE PHARMACIST ASSESSMENT IS THE EVENT BURN SECOND DEGREE IS MEDICALLY SIGNIFICANT AND RELATED TO THE PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW UP ((B)(6) 2016): NEW INFORMATION RECEIVED FROM PHARMACIST INCLUDED: PATIENT AGE, MEDICAL HISTORY, CONCOMITANT MEDICATION, SUSPECT PRODUCT UPDATED TO THERMACARE LOWER BACK & HIP, NEW EVENT (BURN SECOND DEGREE), EVENT TREATMENT AND OUTCOME, AND REPORTER ASSESSMENT. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN SECOND DEGREE WITH BLISTER" AS DESCRIBED IN THIS CASE IS CONSIDERED A SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, AND THE EVENT IS ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THIS CASE MEETS INITIAL 10-DAY EU AND 30-DAY FDA REPORTABILITY. FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. CASE COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN SECOND DEGREE WITH BLISTER" AS DESCRIBED IN THIS CASE IS CONSIDERED A SERIOUS BODILY INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT OF BODY STRUCTURE, AND THE EVENT IS ASSESSED AS ASSOCIATED WITH THE USE OF THE DEVICE. THIS CASE MEETS INITIAL 10-DAY (B)(4) AND 30-DAY FDA REPORTABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43884 | THERMACARE LOWER BACK & HIP | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE | L44146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other| R | L-THYROXIN (LEVOTHYROXINE SODIUM)| L-THYROXIN [DOSAGE FORM:] TABLET |