BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND AID BRAND SHEER BANDAGES

    MDR report key: 10445708 · Received August 24, 2020

    Report

    Report Number
    1000599868-2020-00009
    Event Type
    Injury
    Date Received
    August 24, 2020
    Report Date
    August 24, 2020
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    4901730020022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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 AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON NOVEMBER 5, 2019. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR (BAB SHEER 1INX3IN USA 38137004770 8137004770USA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND AID BRAND SHEER STD 50 AP 4901730020022 3720612204APA). CONSUMER ALSO REPORTED ADVERSE EVENTS FOR TWO BAND-AID WATERBLOCK STRIPS 40 AP 4901730020527. HOWEVER THERE IS NO SIMILAR DEVICE MARKETED IN THE USA. THEREFORE, ADDITIONAL EMDR REPORTS WERE NOT SUBMITTED FOR THIS PRODUCT. UDI: (B)(4). LOT NUMBER = (10) 191105. EXPIRATION DATE = N/A. UDI: (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND AID BRAND SHEER STD 50 AP 4901730020022 3720612204APA). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS INITIAL MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE CONSUMER MIXED 1 BOX OF BAND-AID SHEER STRIPS AND 2 BOXES OF BAND-AID WATERBLOCK STRIPS AND USED THEM. THE CONSUMER APPLIED THE PRODUCT TO WOUND BY REPLACING IT WITH A NEW ONE ONCE A HALF DAY. THE CONSUMER EXPERIENCED A RASH THAT WAS CRUSHED, THE SKIN WAS PEELED OFF, AND IT TURNED YELLOW AND WAS WEEPING. THE CONSUMER STOPPED USING THE PRODUCT AND VISITED A DERMATOLOGY OFFICE. HOWEVER, THE CAUSE OF THE SYMPTOMS WERE UNKNOWN. CONSUMER STATED THAT THEY WERE ADMITTED TO THE HOSPITAL RELATED TO THIS EVENT. AS OF THIS REPORTING, THE CONSUMER TOOK AN ANTIBIOTIC AND APPLIED AN OINTMENT TO THE AFFECTED AREA. THE SYMPTOMS IMPROVED AFTER STOPPING USE OF THE PRODUCT, BUT THE CONSUMER IS STILL EXPERIENCING SYMPTOMS. THIS REPORT IS FOR (BAB SHEER 1INX3IN USA 38137004770 8137004770USA). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND AID BRAND SHEER STD 50 AP 4901730020022 3720612204APA). THE CONSUMER ALSO REPORTED ADVERSE EVENTS FOR TWO BAND-AID WATERBLOCK STRIPS 40 AP 4901730020527. HOWEVER, THERE IS NO SIMILAR DEVICE MARKETED IN THE USA. THEREFORE, ADDITIONAL EMDR REPORTS WERE NOT SUBMITTED FOR THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909279 BAND AID BRAND SHEER BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 4901730020022 191105 4901730020022

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R