BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BANDGRIP

    MDR report key: 14267390 · Received May 2, 2022

    Report

    Report Number
    MW5109480
    Event Type
    Injury
    Date Received
    May 2, 2022
    Date of Event
    April 26, 2022
    Report Date
    April 29, 2022
    Manufacturer
    BANDGRIP INC.
    Product Code
    MKY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BANDGRIP WAS USED ON MY LEFT KNEE AS A WAY TO KEEP MY INCISION CLOSED. IT CAUSED ME TO HAVE TRAUMA TO THE SKIN RESULTS IN NUMEROUS BLISTERS AND SORES. I REACHED OUT TO MY SURGEON WHO TOLD ME TO JUST REMOVE THEM MYSELF. WE DIDN'T FEEL COMFORTABLE SO I WENT TO A DIFFERENT, LOCAL ORTHOPEDIC DR WHO REMOVED THEM AND ADDRESSED THE OPEN BLISTERS AND WOUNDS CAUSED BY BANDGRIP. WHEN I SEND PHOTOS TO THE SURGEON WHO USED THEM, HIS TEAM SAID "THIS CAN HAPPEN AFTER SURGERY WHEN THE BANDGRIP IS ON AND THE KNEE SWELLS IT CAN CAUSE BLISTERS." IF I HAD KNOWN THIS I WOULD HAVE REFUSED THEM. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218656 BANDGRIP SYSTEM, SKIN CLOSURE MKY BANDGRIP INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention ASPRIN 81MG PREVENT BLOOD CLOTS | IBUPROFEN 800MG 3X A DAY| NORCO 7.5-325 EVERY 4-5HRS FOR PAIN | OXY 5MG FOR BREAKTHROUGH PAIN | PANTOPRAZOLE | PROBIOTICS| SIENNA- STOOL SOFTENER | ZOFRAN- NAUSEA FROM PAIN MEDS