BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAB TOUGH STRIPS

    MDR report key: 7739526 · Received August 1, 2018

    Report

    Report Number
    8041154-2018-00010
    Event Type
    Injury
    Date Received
    August 1, 2018
    Date of Event
    June 30, 2018
    Report Date
    August 6, 2018
    Manufacturer
    JOHNSON & JOHNSON CONSUMER INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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 FEBRUARY 3, 2018. 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 ETHNICITY AND RACE WAS NOT PROVIDED FOR REPORTING. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: DRUG: NEOSPORIN PLUS PAIN RELIEF CREAM; 1X DAY; COVER WOUND, DRUG: 6 MEDICATIONS DAILY FOR THE HEART STENTS - CONSUMER DID KNOW EXACT NAMES/INFORMATION. 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. 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)., MALE CONSUMER CALLED TO REPORT HE DEVELOPED A RASH AFTER USING A TOUGH STRIP BAND-AID AND NEOSPORIN PLUS PAIN RELIEF CREAM. HE USED ONE TOUGH STRIP BAND-AID AND AN UNKNOWN AMOUNT OF NEOSPORIN PLUS PAIN RELIEF CREAM ON (B)(6) 2018 AT NIGHT. HE REMOVED THE BAND-AID ON (B)(6) 2018. HE SAW A RASH UNDER ONE END OF THE ADHESIVE. HE SAID THE RASH SPREAD TO THE SIZE OF ABOUT 2 1/2 INCHES TO 3 INCHES. HE WENT TO THE DOCTOR AND GOT A PRESCRIPTION FOR KETOCONAZOLE CREAM TO APPLY TO THE AREA. KETOCONAZOLE CREAM WAS PRESCRIBED FOR 2 TIMES A DAY SINCE (B)(6) 2018. HE WENT BACK TO THE DOCTOR AND GOT A DIFFERENT PRESCRIPTION. HE DID NOT KNOW THE NAME OF THE PRESCRIBED CREAM. HE IS NOT RECOVERED. HE STATES THE RASH REMAINS THE SAME. HE IS NOT PLANNING ON USING THE TOUGH STRIPS OR NEOSPORIN AGAIN. HE IS WORKING WITH HIS HCP FOR HIS RASH AND WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580942 BAB TOUGH STRIPS ADHESIVE BANDAGES KGX JOHNSON & JOHNSON CONSUMER INC 381371155675 0348B

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention NEOSPORIN PLUS PAIN RELIEF CREAM| SIX (6) OTHER UNKNOWN MEDICATIONS| NEOSPORIN PLUS PAIN RELIEF CREAM| SIX (6) OTHER UNKNOWN MEDICATIONS