BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHLN BLK 18IN 6-0 S/A P-1 PRM

    MDR report key: 9460277 · Received December 12, 2019

    Report

    Report Number
    2210968-2019-90823
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    November 20, 2019
    Report Date
    November 20, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    UDI-DI
    10705031008540
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 01/14/2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT PAH143, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 01/14/2020. CORRECTION TO MEDWATCH FOLLOW-UP 1. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT PAH143, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND THE SUTURE WAS USED. THE SUTURE POPPED OFF OF THE NEEDLE IN THE PROCEDURE WITH MUCH LESS PRESSURE THAN A DOCTOR WAS USED TO. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256824 ETHLN BLK 18IN 6-0 S/A P-1 PRM SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. PAH143 10705031008540

    Patients

    Seq Age Sex Outcome Treatment
    1