BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 1822866 · Received August 30, 2010

    Report

    Report Number
    2210968-2010-00990
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THE ACTUAL DEVICE AND BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS AND BATCH NUMBERS: PDS II PLUS ANTIBACTERIAL SUTURE PRODUCT CODE (B)(4): BATCH BPM813 MFG DATE: 12/01/2009, EXP DATE: 07/31/2011. BATCH CA6488 MFG DATE: 01/21/2010, EXP DATE: 01/31/2012. PDS II (POLYDIOXANONE) SUTURE PRODUCT CODE (B)(4): BATCH XP5CKQN MFG DATE: 12/28/2006, EXP DATE: 12/31/2011. BATCH XL5DKXN MFG DATE: 11/08/2006, EXP DATE: 12/31/2011. BATCH ZK5BCBN MFG DATE: 09/11/2007, EXP DATE: 12/31/2012. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. FASCIA WAS CLOSED WITH THE SUTURE. FOLLOWING THAT, THE PATIENT WAS RUSHED 72 - 84 HOURS POST-OPERATIVELY BACK TO THE OPERATING ROOM WITH WOUND DEHISCENCE AS THE SUTURE HAD SNAPPED ALONG THE SUTURE LINE. THE KNOTS TO THE SUTURE WERE INTACT AND THE BREAK OCCURRED ALONG THE MATERIAL LINE. THE PATIENT IS NOW DOING WELL FOLLOWING A RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SUTURE PRODUCT SUTURE GAN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention