BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOHNSON & JOHNSON FIRSTAID

    MDR report key: 532952 · Received June 10, 2004

    Report

    Report Number
    MW1032353
    Event Type
    Injury
    Date Received
    June 10, 2004
    Date of Event
    June 9, 2004
    Report Date
    June 10, 2004
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS CO.
    Product Code
    KGX
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR USED JOHNSON & JOHNSON 1" ALL PURPOSE CLOTH TAPE, LOT 3616B, TO TAPE DOWN THE GLUED EARS OF THEIR AIREDALE PUP. AIREDALE EARS ARE GLUED TO LAY IN THE PROPER POSITION AS ADULTS. THE TAPE WAS STRUNG AROUND THE HEAD TO HOLD DOWN THE TIPS OF THE EARS SO THE PUP COULD NOT DISLODGE THE GLUED EARS. THIS PROCEDURE HAS NEVER RESULTED IN A PROBLEM UNTIL NOW. WITHIN 3 DAYS, THE PUPPY HAD SEEPING SORES UNDER THE TAPE. REMOVING THE TAPE WAS EXTREMELY PAINFUL AS THE VET SAID THAT THE SORE SPOTS WERE EQUIVALENT TO BURNS IN HUMANS. THEIR PUPPY REQUIRED HEAVY SEDATION TO CLEAN AND MEDICATION AS THE PAIN WAS UNBEARABLE. PUPPY HAD ALSO DEVELOPED A TEMPERATURE OF 104 DEGREES BY THE TIME SHE WAS SEEN BY THE VET. J&J ADVERTISES THIS TAPE AS "STRONG, DURABLE AND BREATHABLE FOR LONG-LASTING PROTECTION. DERMALOGICALLY TESTED FOR SENSITIVE SKIN". WHEN RPTR REPORTED THE INCIDENT TO J&J, THE FIRST REACTION WAS THAT THIS PRODUCT IS FOR HUMANS AND HAD NEVER BEEN TESTED FOR ANIMALS. RPTR EXPLAINED TO THEM THAT FIRST-AID PRODUCTS PURCHASED IN A DRUG STORE SHOULD BE SAFE FOR ANIMALS UNLESS OTHERWISE STATED. THEIR COMPLAINT WAS NOTED. ANOTHER LITTER PUPPY HAD THE SAME EAR PROCEDURE USING THE J&J TAPE AT THE SAME TIME. RPTR LEARNED LAST NIGHT THAT THE TAPE HAD TO BE REMOVED ALSO BECAUSE AN IRRITATION WAS DEVELOPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHNSON & JOHNSON FIRSTAID ALL PURPOSE CLOTH TAPE 1' ROLL KGX JOHNSON & JOHNSON CONSUMER PRODUCTS CO. * 3613B

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention