THERMACARE NECK, SHOULDER & WRIST
Report
- Report Number
- 1066015-2016-00141
- Event Type
- Injury
- Date Received
- November 3, 2016
- Date of Event
- October 27, 2016
- Report Date
- October 28, 2016
- 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). THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING AND TECHNICAL 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. AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER ALLEGES BURN FROM WRAP. THE CAUSE OF THE ALLEGED BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL.
THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING AND TECHNICAL 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. AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER ALLEGES BURN FROM WRAP. THE CAUSE OF THE ALLEGED BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL.
THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING AND TECHNICAL 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. AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER ALLEGES BURN FROM WRAP. THE CAUSE OF THE ALLEGED BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL.
EVENT VERBATIM [PREFERRED TERM] 3 CM BURN BLISTER WITH FLUID COLLECTION ON NECK [BURNS SECOND DEGREE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA LOCAL DEPARTMENT. THIS PHARMACIST REPORTED ABOUT HERSELF. A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST, LOT NUMBER N15774, EXPIRATION DATE 27OCT2016), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM (B)(6) 2016 FOR SHOULDER NECK TENSION. THE PATIENT MEDICAL HISTORY INCLUDED DIABETES TYPE 1 (PUMP WELL ADJUSTED) AND THE PATIENT'S CONCOMITANT MEDICATIONS INCLUDED NOT FURTHER SPECIFIED CONTRACEPTIVES. THE PATIENT EXPERIENCED A 2 CM SIZED BURN BLISTER ON (B)(6) 2016 (SOME HOURS AFTER ADMINISTRATION). ON (B)(6) 2016 AT 9:30 A.M. THE PATIENT APPLIED THE THERMACARE HEATWRAP TO HER NECK FOR SHOULDER NECK TENSION. THERMACARE HAD BEEN USED IN THE PAST AND BEEN TOLERATED WELL. SHE DID NOT USE ANYTHING LIKE A SCARF OR SUCH TO FIX THE WRAP. PATIENT FELT COMFORTABLE WARMTH. IN THE EVENING AT 7 P.M. (19:00) THE WRAP WAS REMOVED AND THE PATIENT HAD NO COMPLAINTS. ON (B)(6) 2016 THE PATIENT THEN NOTICED A BIG 3 CM BURN BLISTER ON HER NECK. THE WOUND WAS TREATED BY HER PHYSICIAN, PIERCED WITH A STERILE NEEDLE AND WRAPPED WITH A STERILE PLASTER DUE TO FLUID DISCHARGE. NO SURGICAL INTERVENTION WAS NEEDED BUT WOUND TREATMENT FROM (B)(6) 2016 WAS NECESSARY. IT WAS EXPECTED THAT THE WOUND WILL SCAR. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN ON (B)(6) 2016. THE OUTCOME OF THE EVENT WAS UNKNOWN. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING AND TECHNICAL 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. AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER ALLEGES BURN FROM WRAP. THE CAUSE OF THE ALLEGED BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (10NOV2016): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED INVESTIGATIONAL RESULTS. FOLLOW-UP (12DEC2016): NEW INFORMATION RECEIVED FROM A CONTACTABLE PHARMACIST INCLUDES: PATIENT DATE OF BIRTH, MEDICAL HISTORY AND CONCOMITANT DRUGS, THERAPY DATE AND ACTION TAKEN FOR THE PRODUCT THERMACARE HEATWRAP AND SPECIFIED TREATMENT FOR THE EVENT BURN BLISTER. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: FOR THE SIGNIFICANT FOLLOW-UP ON 12DEC2016, "ADDITIONAL INFO" CHECKBOX SHOULD HAVE BEEN TICKED IN THE PRODUCTS TAB, DEVICE SUB-TAB, DEVICE M/W INFO DIALOG BOX, NOT "DEVICE EVALUATION". 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, 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.
A 2 CM SIZED BURN BLISTER [BURNS SECOND DEGREE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA LOCAL DEPARTMENT. THIS PHARMACIST REPORTED ABOUT HERSELF. A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST, LOT NUMBER N15774, EXPIRATION DATE UNKNOWN), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM (B)(6) 2016 FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT EXPERIENCED A 2 CM SIZED BURN BLISTER ON (B)(6) 2016 (SOME HOURS AFTER ADMINISTRATION) WITH OUTCOME OF UNKNOWN. HE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS UNKNOWN. MEDICAL TREATMENT WAS TAKEN AS A RESULT OF THE EVENT. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING AND TECHNICAL 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. AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER ALLEGES BURN FROM WRAP. THE CAUSE OF THE ALLEGED BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (10NOV2016): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED INVESTIGATIONAL RESULTS. 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 FOLLOW UP 10-DAY EU AND 30-DAY FDA REPORTABILITY., 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 FOLLOW UP 10-DAY EU AND 30-DAY FDA REPORTABILITY.
EVENT VERBATIM [PREFERRED TERM]: A 3 CM BURN BLISTER WITH FLUID COLLECTION ON NECK [BURNS SECOND DEGREE]. CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA LOCAL DEPARTMENT. THIS PHARMACIST REPORTED ABOUT HERSELF. A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST, LOT NUMBER N15774, EXPIRATION DATE 27OCT2016), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM (B)(6) 2016 FOR SHOULDER NECK TENSION. THE PATIENT MEDICAL HISTORY INCLUDED DIABETES TYPE 1 (PUMP WELL ADJUSTED) AND THE PATIENT'S CONCOMITANT MEDICATIONS INCLUDED NOT FURTHER SPECIFIED CONTRACEPTIVES. THE PATIENT EXPERIENCED A 2 CM SIZED BURN BLISTER ON (B)(6) 2016 (SOME HOURS AFTER ADMINISTRATION). ON (B)(6) 2016 AT 9:30 A.M. THE PATIENT APPLIED THE THERMACARE HEATWRAP TO HER NECK FOR SHOULDER NECK TENSION. THERMACARE HAD BEEN USED IN THE PAST AND BEEN TOLERATED WELL. SHE DID NOT USE ANYTHING LIKE A SCARF OR SUCH TO FIX THE WRAP. PATIENT FELT COMFORTABLE WARMTH. IN THE EVENING AT 7 P.M. (19:00) THE WRAP WAS REMOVED AND THE PATIENT HAD NO COMPLAINTS. ON (B)(6) 2016, THE PATIENT THEN NOTICED A BIG 3 CM BURN BLISTER ON HER NECK. THE WOUND WAS TREATED BY HER PHYSICIAN, PIERCED WITH A STERILE NEEDLE AND WRAPPED WITH A STERILE PLASTER DUE TO FLUID DISCHARGE. NO SURGICAL INTERVENTION WAS NEEDED BUT WOUND TREATMENT FROM (B)(6) 2016 WAS NECESSARY. IT IS EXPECTED THAT THE WOUND WILL SCAR. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS PERMANENTLY WITHDRAWN ON (B)(6) 2016. THE OUTCOME OF THE EVENT WAS UNKNOWN. ACCORDING TO THE PRODUCT QUALITY COMPLAINT GROUP: THE ROOT CAUSE CATEGORY IS NON ASSIGNABLE (COMPLAINT NOT CONFIRMED). THE PLANT HAS REVIEWED THIS BATCH FROM A MANUFACTURING AND TECHNICAL 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. AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. CONSUMER ALLEGES BURN FROM WRAP. THE CAUSE OF THE ALLEGED BURN IS INCONCLUSIVE SINCE REVIEW OF RECORDS DOES NOT PROVIDE EVIDENCE TO SUPPORT DEFECTIVE PRODUCT. THE PRODUCT EFFECT MAY VARY WITH EACH INDIVIDUAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. FOLLOW-UP (10NOV2016): NEW INFORMATION RECEIVED FROM THE PRODUCT QUALITY COMPLAINT GROUP INCLUDED INVESTIGATIONAL RESULTS. FOLLOW-UP (12DEC2016): NEW INFORMATION RECEIVED FROM A CONTACTABLE PHARMACIST INCLUDES: PATIENT DATE OF BIRTH, MEDICAL HISTORY AND CONCOMITANT DRUGS, THERAPY DATE AND ACTION TAKEN FOR THE PRODUCT THERMACARE HEATWRAP AND SPECIFIED TREATMENT FOR THE EVENT BURN BLISTER. 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., 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.
EVENT VERBATIM [PREFERRED TERM] A 2 CM SIZED BURN BLISTER [BURNS SECOND DEGREE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE PHARMACIST VIA LOCAL DEPARTMENT. THIS PHARMACIST REPORTED ABOUT HERSELF. A (B)(6) FEMALE PATIENT OF AN UNSPECIFIED ETHNICITY STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE NECK, SHOULDER & WRIST, LOT NUMBER N15774, EXPIRATION DATE UNKNOWN), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM (B)(6) 2016 FOR AN UNSPECIFIED INDICATION. THE PATIENT MEDICAL HISTORY AND THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT EXPERIENCED A 2 CM SIZED BURN BLISTER ON (B)(6) 2016 (SOME HOURS AFTER ADMINISTRATION) WITH OUTCOME OF UNKNOWN. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR THERMACARE HEATWRAP WAS UNKNOWN. MEDICAL TREATMENT WAS TAKEN AS A RESULT OF THE EVENT. 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., 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726749 | THERMACARE NECK, SHOULDER & WRIST | DISPOSABLE PACK, HOT | IMD | PFIZER CONSUMER HEALTH CARE | N15774 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |