BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB FLEXIBLE FABRIC BANDAGES

    MDR report key: 13891289 · Received March 24, 2022

    Report

    Report Number
    1000599868-2022-00004
    Event Type
    Injury
    Date Received
    March 24, 2022
    Report Date
    June 2, 2022
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    UDI-DI
    381370044345
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. THIS REPORT IS FOR ONE (1) BAB FLEXIBLE FABRIC 3/4IN 100S USA 381370044345, 8137004434USA 8137004434USA, LOT/CTRL # 200508. UDI #: (B)(4). UPC #: 381370044345. LOT #:200508. EXP DATE:NA. 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 HAS BEEN REQUESTED. THIS IS 1 OF 5 MED-WATCHES BEING SUBMITTED AS FIVE POTENTIAL DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES: 8041154-2022-00002, 1000599868-2022-00005, 1000599868-2022-00006, 1000599868-2022-00007. 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.

    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. H4, H6: 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 MAY 8, 2020. 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

    A FEMALE CONSUMER REPORTED USING BAB FLEXIBLE FABRIC BAND AIDS ON HER CHEST AFTER HAVING A SURGERY IN (B)(6) 2021. CONSUMER STATED SHE DEVELOPED ITCHING ON/IN CHEST AND THROAT. CONSUMER STATED SHE COULD NOT BREATH AND THAT THE PRODUCTS BURNED HER CHEST. CONSUMER SOUGHT MEDICAL INTERVENTION AND WAS TREATED BY PHYSICIAN WITH INHALERS AND STEROIDS VIA ORAL ADMINISTRATION. THERE IS NO ADDITIONAL INFORMATION WITH REGARD TO OUTCOME FOR THIS CONSUMER. THIS IS 1 OF 5 MED-WATCHES BEING SUBMITTED AS FIVE POTENTIAL DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES: 8041154-2022-00002, 1000599868-2022-00005, 1000599868-2022-00006, 1000599868-2022-00007. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134784 BAB FLEXIBLE FABRIC BANDAGES TAPE AND BANDAGE, ADHESIVE KGX JOHNSON & JOHNSON CONSUMER INC 381370044345 200508 381370044345

    Patients

    Seq Age Sex Outcome Treatment
    1 Female