BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB SHEER BANDAGES

    MDR report key: 12001134 · Received June 15, 2021

    Report

    Report Number
    8041154-2021-00012
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    April 20, 2021
    Report Date
    July 20, 2021
    Manufacturer
    CONSUMER JOHNSON & JOHNSONS INC
    Product Code
    KGX
    Adverse Event
    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. THE CONSUMER HAS REPORTED A BAND AID WAS USED AND MAY HAVE CONTRIBUTED TO THE EVENT, THE FOLLOWING PRODUCTS ARE POSSIBLE DEVICES THAT WERE USED FROM THIS KIT: BAB SHEER ASSORTED 80S, 8137004669USA. BAB CLEAR WATER BLOCK PLUS 30S, 8137005659USA. THIS IS 1 OF 2 FOLLOW-UP MED-WATCHES BEING SUBMITTED AS TWO POSSIBLE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2021-00013. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    BASED ON ADDITIONAL INFORMATION RECEIVED FROM CONSUMER, IT WAS ALSO REPORTED THAT CONSUMER EXPERIENCED IRRITATION, BURNING AND REDNESS WHILE USING THIS PRODUCT. THE IRRITATION, BURNING AND REDNESS WENT AWAY AFTER SHE STOPPED USING THE PRODUCT HOWEVER, SHE'S STILL WAITING FOR THE IRRITATION TO GO AWAY COMPLETELY AND THERE'S STILL DISCOLORATION ON HER ARM. THE CONSUMER WAS USING THE PRODUCT TWICE DAILY. THE CONSUMER HAS REPORTED A BAND AID WAS USED AND MAY HAVE CONTRIBUTED TO THE EVENT, THE FOLLOWING PRODUCTS ARE POSSIBLE DEVICES THAT WERE USED FROM THIS KIT: BAB SHEER ASSORTED 80S, 8137004669USA. BAB CLEAR WATER BLOCK PLUS 30S, 8137005659USA. THIS IS 1 OF 2 FOLLOW-UP MED-WATCHES BEING SUBMITTED AS TWO POSSIBLE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2021-00013. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT AND ETHNICITY WERE NOT PROVIDED FOR REPORTING. UDI: (B)(4), UPC = (01)381370046691, EXPIRATION DATE= NA, LOT NUMBER =NI. THIS REPORT IS FOR ONE (1) BAB SHEER ASSORTED 80S (B)(4), LOT NUMBER NI. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 LOT NUMBER. THE CONSUMER HAS REPORTED A BAND AID WAS USED AND MAY HAVE CONTRIBUTED TO THE EVENT, THE FOLLOWING PRODUCTS ARE POSSIBLE DEVICES THAT WERE USED FROM THIS KIT: BAB SHEER ASSORTED 80S, (B)(4). BAB CLEAR WATER BLOCK PLUS 30S, (B)(4). THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO POSSIBLE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2021-00013. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. 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

    AN EVENT WAS REPORTED WITH A BAND AID FROM BAND-AID ALL-PURPOSE FIRST AID KIT PORTABLE COMPACT 140 PCS. IT WAS REPORTED THAT THE CONSUMER'S RIGHT HAND GOT INJURED BECAUSE OF THE BANDAGE. THE CONSUMER HAD EXPERIENCED, SCARRING, ITCHING, AND DISCOLORATION AFTER USE OF THE PRODUCT. THE CONSUMER PROVIDED FOLLOW-UP INFORMATION AND STATED SHE WENT TO THE HOSPITAL AND WAS PRESCRIBED ANTIBIOTICS FOR HER MEDICAL EVENT. THE CONSUMER STATED SHE ONLY USED 1 PAD. THE CONSUMER HAS REPORTED A BAND AID WAS USED AND MAY HAVE CONTRIBUTED TO THE EVENT, THE FOLLOWING PRODUCTS ARE POSSIBLE DEVICES THAT WERE USED FROM THIS KIT: BAB SHEER ASSORTED 80S, (B)(4). BAB CLEAR WATER BLOCK PLUS 30S, (B)(4). THIS IS 1 OF 2 MED-WATCHES BEING SUBMITTED AS TWO POSSIBLE DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 8041154-2021-00013. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897102 BAB SHEER BANDAGES TAPE AND BANDAGE, ADHESIVE KGX CONSUMER JOHNSON & JOHNSONS INC 381370046691

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention