BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 1935760 · Received December 16, 2010

    Report

    Report Number
    2210968-2010-01684
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K960653
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500 FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A HYSTEROTOMY PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. THE SURGEON FELT THAT THE NEEDLE WAS DULLER THAN USUAL, BUT HE KEPT USING IT DURING CONTINUOUS SUTURING AT THE UTERUS. AFTER SUTURING, THE NURSE FOUND THAT THE NEEDLE HAD BROKEN AT THE TIP. THE FRAGMENT COULD NOT BE FOUND THOUGH THE PT UNDERWENT X-RAY AND STAFF LOOKED FOR IT IN THE OPERATION ROOM. THE SURGEON SUSPECTED THAT THE NEEDLE HAD BEEN BROKEN AT THE TIP AT THE FIRST. THERE WERE NO ADVERSE PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK