BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE UNKNOWN

    MDR report key: 10073401 · Received May 19, 2020

    Report

    Report Number
    2210968-2020-04033
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Report Date
    May 12, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO RECEIVE A DEVICE FOR EVALUATION. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: QUESTIONS: WHAT IS THE EVENT DAY? WHAT IS THE PROCEDURE DATE? COULD YOU PLEASE PROVIDE PRODUCT CODE? COULD YOU PLEASE PROVIDE LOT NUMBER? DEVICE RETURN FOLL. ANSWERS: I DON¿T HAVE THE CODE: I NEED YOU TO SEND SHIPPER KIT TO CONTACT SO THEY CAN ADD DEVICE SINCE I AM NOT ALLOWED TO GO IN THE DATE WAS (B)(6) 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2020 AND UNKNOWN SUTURE WAS USED. IT WAS REPORTED THAT DURING THE PROCEDURE CLOSING OAF PERITONEUM, THE NEEDLE BROKE OFF. ANOTHER LIKE SUTURE/NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537050 SUTURE UNKNOWN SUTURE, NONABSORBABLE GAO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1