BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACARE NECK, SHOULDER & WRIST

    MDR report key: 7247320 · Received February 7, 2018

    Report

    Report Number
    1066015-2018-00015
    Event Type
    Injury
    Date Received
    February 7, 2018
    Report Date
    November 30, 2017
    Manufacturer
    PFIZER CONSUMER HEALTH CARE
    Product Code
    IMD
    PMA / PMN Number
    K953442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED). CONSUMER REPORTS A "HEAT WRAP CAUSED BURN AND PAIN AFTER APPLICATION". THE CAUSE OF THE BURN 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. AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. THE PRODUCT QUALITY FOR THE BATCH IS NOT IMPACTED BY THIS COMPLAINT.

    Description of Event or Problem · 1

    BURN BLISTER FIRST DEGREE, APPROXIMATELY 2 SQCM/BURN AND PAIN AFTER APPLICATION [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 NECK, SHOULDER AND WRIST) (DEVICE LOT NUMBER S16669, EXPIRATION DATE NOV2019) FROM AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT SUFFERED FROM BURN AND PAIN AFTER APPLICATION OF THERMACARE NECK, SHOULDER AND WRIST. THE EVENT WAS DESCRIBED AS "BURN BLISTER FIRST DEGREE, APPROXIMATELY 2 SQ CM", NO SURGICAL TREATMENT WAS NECESSARY, NO LONG-TERM DAMAGE WAS EXPECTED. PATIENT WAS TREATED WITH "BURN AND WOUND GEL". EVENT OUTCOME WAS UNKNOWN. INVESTIGATION SUMMARY: THE ROOT CAUSE CATEGORY IS NON-ASSIGNABLE (COMPLAINT NOT CONFIRMED). CONSUMER REPORTS A "HEAT WRAP CAUSED BURN AND PAIN AFTER APPLICATION". THE CAUSE OF THE BURN 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. AFTER A REVIEW OF THE BATCH THERMAL RECORDS, THERMAL RESULTS ALL MET PRODUCT RELEASE CRITERIA. 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 (20DEC2017): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDES: PRODUCT QUALITY INVESTIGATION RESULTS. FOLLOW-UP (22JAN2018): NEW INFORMATION FROM CONTACTABLE PHARMACIST INCLUDED: NEW EVENT (BURN BLISTER FIRST DEGREE, APPROXIMATELY 2 SQ CM), TREATMENT RECEIVED AND CASE UPGRADED TO SERIOUS. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THE EVENT OF "BURN BLISTER" 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 BLISTER" 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
    93717 THERMACARE NECK, SHOULDER & WRIST DISPOSABLE PACK, HOT IMD PFIZER CONSUMER HEALTH CARE S16669

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention