BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPE HY-TAPE 1"X5YD

    MDR report key: 18474557 · Received January 8, 2024

    Report

    Report Number
    MW5149929
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Report Date
    January 4, 2024
    Manufacturer
    HY-TAPE INTERNATIONAL, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENTS HUSBAND REPORTED THAT HE RECEIVED 8-9 DEFECTIVE ROLLS OF HY-TAPE (STATED LOT# 7062708). HUSBAND STATES THAT IT APPEARS THAT THE ROLLS WERE NOT WRAPPED CORRECTLY THAT HALF OF THE TAPE WAS NOT ALIGNED WITH THE REST SO PART OF THE TAPE IS EXPOSED AND NOT SANITARY; THAT THEY WERE ROLLED UP CROOKED. HUSBAND STATES THAT HE WILL STILL USE THEM SINCE FORTUNATELY NOT BEING PLACED ON OPEN SITE/SKIN. PATIENT DID NOT MISS DOSE. PATIENT DID NOT EXPERIENCE ADVERSE EVENT. UNKNOWN IF PATIENT HAS PRODUCT ON HAND FOR RETURN. REPLACING WITH TWO NEW ROLLS PER HUSBAND REQUEST. NO FURTHER INFORMATION PROVIDED. NO SIDE EFFECTS REPORTED. EVENT DATES ARE UNKNOWN AS NOT REPORTED. #110BLF. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER. REFERENCE REPORTS: MW5149923, MW5149924, MW5149925, MW5149926, MW5149927, MW5149928, MW5149930.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003084 TAPE HY-TAPE 1"X5YD TAPE AND BANDAGE, ADHESIVE KGX HY-TAPE INTERNATIONAL, INC. 7062708

    Patients

    Seq Age Sex Outcome Treatment
    1 Female AMBRISENTAN.| C-FORMULATION D W/CLONI 0.2%. | C-TREPROSTINIL (3ML)RM.