BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1910339 · Received November 24, 2010

    Report

    Report Number
    2210968-2010-01581
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    August 26, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    UNKNOWN

    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 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A NORMAL CESAREAN SECTION PROCEDURE ON (B)(6) 2010. THE PT RETURNED ON (B)(6) 2010 WITH A BURST ABDOMEN. UPON INVESTIGATION, A PORTION OF THE SUTURE WAS ONLY FOUND ON BOTH ENDS OF THE INCISION. THE MID SECTION SUTURE WAS NOT FOUND. THE SURGEON OPINES THAT THE SUTURE WAS THE CAUSE OF THE EVENT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA VE801

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R