BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISURE

    MDR report key: 5043172 · Received August 31, 2015

    Report

    Report Number
    2125050-2015-00087
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    August 16, 2011
    Report Date
    June 24, 2015
    Manufacturer
    COLOPLAST CORP
    Product Code
    OTN
    PMA / PMN Number
    K092203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. RESPONSE MADE BECAUSE DEVICE WAS NOT RETURNED. EXEMPTION NUMBER (B)(4). TOTAL NUMBER OF EVENTS REPORTED: (B)(4). (B)(4) - ARIS TRANSOBTURATOR. (B)(4) - MINITAPE. (B)(4) - OMNISURE. (B)(4) - SUPRIS SUPRAPUBIC/RETROPUBIC. DEVICE NOT EXPLANTED OR RETURNED.

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. RESPONSE MADE BECAUSE DEVICE WAS NOT RETURNED. EXEMPTION NUMBER (B)(4). TOTAL NUMBER OF EVENTS REPORTED: (B)(4). (B)(4) -ARIS TRANSOBTURATOR. (B)(4) - MINITAPE. (B)(4)- OMNISURE. (B)(4) - SUPRIS SUPRAPUBIC/RETROPUBIC. DEVICE NOT EXPLANTED OR RETURNED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH OMNISURE MESH. LATER THE PATIENT EXPERIENCED MESH EXPOSED AT THE TOP OF THE VAGINA AND DYSPAREUNIA. MESH REVISION, EXPOSED MESH REMOVED, NO MENTION OF SIZE OF EXCISED MESH, WERE PERFORMED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH OMNISURE MESH. LATER THE PATIENT EXPERIENCED MESH EXPOSED AT THE TOP OF THE VAGINA AND DYSPAREUNIA. MESH REVISION, EXPOSED MESH REMOVED, NO MENTION OF SIZE OF EXCISED MESH, WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575241 OMNISURE SURGICAL MESH OTN COLOPLAST CORP K10101201

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other| R