BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVESCO CLIP

    MDR report key: 6521967 · Received April 23, 2017

    Report

    Report Number
    MW5069331
    Event Type
    Injury
    Date Received
    April 23, 2017
    Date of Event
    April 10, 2017
    Report Date
    April 23, 2017
    Manufacturer
    OVESCO
    Product Code
    PKL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I'VE HAD ULCERATIVE COLITIS FOR 4 YEARS AND LAST YEAR UNDERWENT SURGERIES TO REMOVE MY COLON AND CREATE AN INTERNAL J-POUCH OR IPAA. THERE WERE HOLES IN THE J-POUCH AND MY SURGEON AT THE (B)(6) CLINIC IN (B)(6) USED OVESCO CLIPS TO CLOSE THE HOLES. MY LAST SINOGRAM SHOWED THAT THE OVESCO CLIP WAS NOT EFFECTIVE IN SEALING THE LEAK SO I KEEP HAVING REOCCURRING ABSCESSES. MY SURGEON SAID THE CLIP REMOVER HASN'T BEEN FDA APPROVED SO THEY CAN'T REMOVE THE CLIP TO TRY TO RESEAL IT WITH A DIFFERENT METHOD. BECAUSE WE HAVE NO OPTIONS WITH THIS FAULTY CLIP, THEY WANT TO REMOVE MY J-POUCH AND HAVE ME LIVE THE REST OF MY LIFE WITH AN ILEOSTOMY. I NEED TO KNOW WHY THE CLIP WAS APPROVED BUT THE DEVICE TO FIX OR REMOVE THEM WAS NOT! WHAT AM I SUPPOSED TO DO? I WILL NOT LIVE WITH AN OSTOMY BECAUSE THE FDA DIDN'T DUE DILIGENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296342 OVESCO CLIP CLIP PKL OVESCO

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| L| R| S IBUOPROFEN. | NEURONTIN.| OTC MEDS: TYLENOL| OXYCODONE| RX MEDS: AVIANE