BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOHNSON & JOHNSON COACH® SELF-ADHERING SPORTS WRAP

    MDR report key: 7638788 · Received June 26, 2018

    Report

    Report Number
    2214133-2018-00015
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Report Date
    August 21, 2018
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    FQM
    Removal / Correction Number
    Z1202-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PRODUCT WAS RETURNED FOR INVESTIGATION. FIELD SAMPLE WAS VISUALLY INSPECTED AND MISLEADING GRAPHICS/COPY OF & QUOT; NOT MADE WITH NATURAL RUBBER LATEX & QUOT; WAS NOTED ON BACK OF THE PACKAGE. PART OF RECALL NUMBER Z-1202-2018. NO OTHER APPARENT DEFECTS WERE NOTED WITH THE PRODUCT OR PACKAGING. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2018-00012. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #02 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    JOHNSON & JOHNSON CONSUMER, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH JOHNSON & JOHNSON CONSUMER, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, JOHNSON & JOHNSON CONSUMER, INC. OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, JOHNSON & JOHNSON CONSUMER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING REVIEW: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE FROM RESERVE SAMPLE WAS VISUALLY EVALUATED AND APPEARANCE MET SPECIFICATION. RETAIN ANALYSIS CODE: 11- TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER, NO FAILURE DETECTED. PART OF RECALL NUMBER Z-1202-2018. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #01 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    . DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UDI NUMBER: (B)(4). UPC = (B)(4). EXPIRATION DATE = NA, LOT NUMBER = (10)1197CA. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DRUG: LEVOTHYROXIN 0.100MG A DAY; UNKNOWN TIMEFRAME; FOR HYPOTHYROIDISM; CONSUMER STILL ON DRUG. DRUG: ALOTAPINE 5MG A DAY: UNKNOWN TIMEFRAME; FOR HIGH BLOOD PRESSURE; CONSUMER STILL ON DRUG. DRUG: SYNTHROID 20MG A DAY: UNKNOWN TIMEFRAME; FOR HIGH CHOLESTEROL; CONSUMER STILL ON DRUG. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THIS TIME AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. (B)(4) LABELING DESIGN - PART OF RECALL NUMBER Z-1202-2018 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD CAUCASIAN FEMALE CONSUMER REPORTED THAT SHE HAS BEEN USING THE J&J COACH SELF ADHERING SPORTS WRAP SINCE (B)(6) 2017 FOR WOUND CARE. CONSUMER STATED THAT SINCE USE OF THE WRAP SHE NOTICED A REDNESS ON HER SKIN WHERE THE WRAP CONTACTS THE SKIN. CONSUMER WAS NOT AWARE IF SHE HAS A LATEX ALLERGY. SHE DID NOT HAVE ANY OTHER ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480856 JOHNSON & JOHNSON COACH® SELF-ADHERING SPORTS WRAP BANDAGE, ELASTIC FQM JOHNSON & JOHNSON CONSUMER INC 381370079293 1197CA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR ALOTAPINE 5MG| LEVOTHYROXIN 0.100MG| SYNTHROID 20MG