BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 3030415 · Received April 2, 2013

    Report

    Report Number
    2210968-2013-03259
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 9, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4) ¿ THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS:BATCH ELK742 MFG DATE: 10/01/2012, EXP DATE: NI.BATCH EMK440 MFG DATE: 11/01/2012, EXP DATE: NI.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 WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY IN (B)(6) 2013 AND SUTURE WAS USED. THE SUTURE WAS KNOTTED WITH A NEEDLE-HOLDER. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2013, THE PATIENT HAD A PUS LIKE PIMPLE AROUND THE INCISION SITE. THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH A SUBCUTANEOUS ABSCESS. THE DOCTOR PICKED THE PUS AND PRESCRIBED AN ANTIBIOTIC. THE DOCTOR IS TAKING A WAIT-AND-SEE APPROACH ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134682 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention