BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL+ UD 18IN 4-0 S/A PS-2 PRM MP

    MDR report key: 14088422 · Received April 12, 2022

    Report

    Report Number
    2210968-2022-02632
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    September 14, 2021
    Report Date
    April 12, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031046597
    PMA / PMN Number
    K050845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? NO. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY. HAD TO OPEN A NEW SUTURE TO CONTINUE CLOSING THE SKIN. COULD YOU TELL ME IF THERE WAS A PRESCRIPTION FOR STEROIDS OR ANTIBIOTICS FOR THE PATIENT'S RECOVERY? IF YES, PLEASE PROVIDE MEDICATION NAME, ROUTE AND DOSE. NO. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME - IRGACARE®, ACTIVE INGREDIENT(S) ¿ TRICLOSAN, DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, STRENGTH: 2360 G/M. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE TISSUE WAS BEING USED ON SKIN/FOREHEAD AND WASN¿T TIED YET. THE SUTURE WAS INITIALLY PLACED INTERRUPTED. THREE TISSUE PASSES HAD OCCURRED BEFORE BREAKAGE. THE APPROXIMATE LOCATION OF THE SUTURE BREAKAGE IS UNSURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146574 MCRYL+ UD 18IN 4-0 S/A PS-2 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. MCP496G REMHEP 10705031046597

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown