BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOHNSON & JOHNSON COACH® SELF-ADHERING SPORTS WRAP

    MDR report key: 7638481 · Received June 26, 2018

    Report

    Report Number
    2214133-2018-00012
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Report Date
    August 21, 2018
    Manufacturer
    JOHNSON AND 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 RELATED TO PART OF RECALL NUMBER (Z-1202-2018) WITHOUT PACKAGING. SAMPLE WAS VISUALLY INSPECTED. NO APPARENT DEFECTS WERE NOTED WITH THE PRODUCT. THIS IS TWO OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2214133-2018-00015. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. 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. ETHNICITY/RACE WAS NOT REPORTED. (B)(4). EXPIRATION DATE = NA. LOT NUMBER = NOT REPORTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ALOTAPINE, 5MG DAY, HAS BEEN TAKING FOR YEARS TO TREAT HIGH BLOOD PRESSURE LEVOTHYROXIN, 0.100MG DAY, HAS BEEN TAKING FOR YEARS TO TREAT HYPOTHYROIDISM SYNTHROID, 20MG DAY, HAS BEEN TAKING FOR YEARS TO TREAT HIGH CHOLESTEROL DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT A LOT NUMBER. (B)(4). 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) 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
    479201 JOHNSON & JOHNSON COACH® SELF-ADHERING SPORTS WRAP BANDAGE, ELASTIC FQM JOHNSON AND JOHNSON CONSUMER INC. 381370079293

    Patients

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