BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE UNKNOWN

    MDR report key: 3535833 · Received December 24, 2013

    Report

    Report Number
    2210968-2013-33549
    Event Type
    Injury
    Date Received
    December 24, 2013
    Report Date
    December 18, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    UNKNOWN
    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: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE HAD A RECTOCELE REPAIR AND ENTEROCELE REPAIR ON (B)(6) 2009 AND SUTURES WAS USED. THE PATIENT HAS COMPLAINED OF INTENSE PAIN SINCE THE PROCEDURE. SHE DEVELOPED THROAT SWELLING AND WAS UNABLE TO EAT SOLIDS FOR 18 MONTHS. THE PATIENT WAS TREATED WITH LIDOCAINE CREAM, TOPICAL HRT, CLINDAMYCIN TOPICAL CREAM, AND STEROID CREAMS ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673926 SUTURE UNKNOWN OTP ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention