THERMACARE LOWER BACK & HIP
Report
- Report Number
- 1066015-2016-00071
- Event Type
- Injury
- Date Received
- April 21, 2016
- Report Date
- April 12, 2016
- 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 INVESTIGATION: THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8 HOUR PRODUCT. CONCLUSION: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THERE IS NOT A PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE 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.
EVENT VERBATIM [PREFERRED TERM] BURN BLISTERS AFTER 1-2 HOURS [BURNS SECOND DEGREE]. NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA FEDERAL UNION OF GERMAN ASSOCIATIONS OF PHARMACISTS (AMK: NO REFERENCE NUMBER PROVIDED). A 55-YEAR-OLD FEMALE PATIENT NOT PREGNANT STARTED TO USE THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) FROM AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. LOT NUMBER AND EXPIRATION DATE WERE NOT AVAILABLE. THE PATIENT'S MEDICAL HISTORY INCLUDED TUMOR DISEASE FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED BURN BLISTERS AFTER 1-2 HOURS OF HEATWRAP USE. NO TREATMENT WAS RECEIVED FOR THE EVENT BURN BLISTERS. ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN ON AN UNSPECIFIED DATE. CLINICAL OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUEL ON AN UNSPECIFIED DATE. NO CAUSALITY RELATIONSHIP PROVIDED. ACCORDING TO PRODUCT QUALITY COMPLAINT GROUP: SUMMARY OF INVESTIGATION: THIS INVESTIGATION WAS CONDUCTED FOR AN UNKNOWN LOT NUMBER LOWER BACK/HIP (LBH) 8 HOUR PRODUCT. CONCLUSION: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED AS A QUALITY DEFECT). THERE WAS LIMITED DEVICE SPECIFIC INFORMATION PROVIDED, NO BATCH NUMBER OR RETURN SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT A BATCH REFERENCE NUMBER AND/OR RETURN SAMPLE A MANUFACTURING AND TECHNICAL EVALUATION CANNOT BE COMPLETED FOR THE WRAP INVOLVED IN THIS CASE. THERE IS NOT A PRODUCT QUALITY RELATED TREND IDENTIFIED FOR THE SUBCLASS ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. THE 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. FOLLOW UP (15APR2016): NEW INFORMATION RECEIVED FROM A CONTACTABLE PHARMACIST VIA FEDERAL UNION OF GERMAN ASSOCIATIONS OF PHARMACISTS: ((B)(4)) INCLUDED TREATMENT (NO TREATMENT WAS NEEDED) AND PRODUCT DATA (NO LOT NUMBER CAN BE PROVIDED). THE OUTCOME FOR THE EVENT BURN BLISTER WAS UPDATED FROM RECOVERED/ RESOLVED WITH SEQUEL TO RECOVERED/RESOLVED. FOLLOW-UP (15APR2016): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: TWO TYPES OF THERMACARE HEATWRAPS WERE MENTIONED IN THE INITIAL REPORT, THERMACARE NECK, SHOULDER & WRIST AND THERMACARE LOWER BACK & HIP. SUSPECT PRODUCTS UPDATED. FOLLOW-UP (09JUN2016): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (13FEB2020): NEW INFORMATION RECEIVED PRODUCT QUALITY COMPLAINT GROUP INCLUDED: INVESTIGATION RESULTS. FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO NOTIFY US FOOD AND DRUG ADMINISTRATION (FDA) THAT MFR REPORT NUMBER 1066015- 2016-00071 AND MFR REPORT NUMBER 1066015-2016- 00074 ARE DUPLICATE. ALL SUBSEQUENT FOLLOW-UP INFORMATION WILL BE REPORTED UNDER MFR REPORT NUMBER 1066015-2016-00071. MFR REPORT NUMBER 1066015- 2016-00074 IS TO BE CONSIDERED AS DELETED.
BURN BLISTER AFTER 1-2 HOURS [BURNS SECOND DEGREE] CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA (B)(6) (AMK: NO REFERENCE NUMBER PROVIDED). A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE HEATWRAP) TRANSDERMAL FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE AT ONE EVERY 8 HOURS FOR MUSCLE TENSION. LOT NUMBER AND EXPIRATION DATE ARE NOT AVAILABLE ANYMORE TO THE PHARMACY. MEDICAL HISTORY INCLUDED TUMOR DISEASE FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT EXPERIENCED BURN BLISTER AFTER 1-2 HOURS ON AN UNSPECIFIED DATE WITH OUTCOME OF RECOVERED WITHOUT SEQUEL. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN ON AN UNSPECIFIED DATE. NO CAUSALITY RELATIONSHIP PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN 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. CASE COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN 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.
CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA (B)(6) (AMK: NO REFERENCE NUMBER PROVIDED). A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO USE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST) FROM AN UNSPECIFIED DATE 1 TIME FOR 8 HOURS FOR MUSCLE TENSION AND THERMACARE HEATWRAP (THERMACARE LOWER BACK & HIP) FROM AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. LOT NUMBERS AND EXPIRATION DATES WERE NOT AVAILABLE. THE PATIENT'S MEDICAL HISTORY INCLUDED TUMOR DISEASE FROM AN UNKNOWN DATE AND UNKNOWN IF ONGOING. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED BURN BLISTERS AFTER 1-2 HOURS OF HEATWRAP USE. NO TREATMENT WAS NEEDED FOR THE EVENT BURN BLISTERS. ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAPS WAS PERMANENTLY WITHDRAWN ON AN UNSPECIFIED DATE. CLINICAL OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUEL ON AN UNSPECIFIED DATE. NO CAUSALITY RELATIONSHIP PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW UP (15APR2016): NEW INFORMATION RECEIVED FROM A CONTACTABLE PHARMACIST VIA (B)(6): (B)(4) INCLUDED TREATMENT (NO TREATMENT WAS NEEDED) AND PRODUCT DATA (NO LOT NUMBER CAN BE PROVIDED). THE OUTCOME FOR THE EVENT BURN BLISTER WAS UPDATED FROM RECOVERED/ RESOLVED WITH SEQUEL TO RECOVERED/RESOLVED. FOLLOW-UP (15APR2016): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: TWO TYPES OF THERMACARE HEATWRAPS WERE MENTIONED IN THE INITIAL REPORT, THERMACARE NECK, SHOULDER & WRIST AND THERMACARE LOWER BACK & HIP. SUSPECT PRODUCTS UPDATED. COMPANY CLINICAL EVALUATION COMMENT BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN BLISTERS" 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 FOLLOW UP 10-DAY EU AND 30-DAY FDA REPORTABILITY. CASE COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT "BURN BLISTERS" 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 FOLLOW UP 10-DAY EU AND 30-DAY FDA REPORTABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249039 | THERMACARE LOWER BACK & HIP | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |