BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE Y SHAPED 27X4CM

    MDR report key: 8728185 · Received June 24, 2019

    Report

    Report Number
    2125050-2019-00496
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    April 6, 2017
    Report Date
    July 22, 2020
    Manufacturer
    COLOPLAST CORP
    Product Code
    OTO
    PMA / PMN Number
    K112322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. THIS MDR HAS BEEN CREATED TO DOCUMENT THE ASR / PRODUCT CODE OTO / EXEMPTION # E2014015. TOTAL NUMBER OF EVENTS: 14. RESTORELLE: 10. NOVASILK: 4 - ATTACHMENT: [OTO SPREADSHEET APRIL 2019-MAY 15, 2019.PDF].

    Additional Manufacturer Narrative · 0

    THIS MDR FOLLOW-UP IS CREATED AS A FOLLOW-UP TO RECORD 501137, INITIALLY REPORTED ON PRODUCT CODE OTO ASR EXEMPTION # E2014015 FOR APRIL (B)(6) 2019. THIS MDR IS TO REFLECT THE ADDITIONAL INFORMATION TO BE ADDED TO THE INTIAL ASR REPORT (DEVICE INFORMATION AND PATIENTS DOB). REVIEW OF THE LOT NUMBER FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA REVIEW. NO TRENDS NOTED. COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 0

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED PLAINTIFF SUFFERED MULTIPLE INFECTIONS, EROSION OF THE MESH, FORMATION OF TWO DISTINCT RECTO-VAGINAL FISTULAS, INTERNAL AND EXTERNAL SCARRING, AND HAD TO UNDERGO A DIVERTING COLOSTOMY. REVISION SURGERIES OCCURRED TO REMOVE THE ERODED MESH.

    Description of Event or Problem · 0

    THIS MDR FOLLOW-UP IS CREATED AS A FOLLOW-UP TO RECORD 501137, INITIALLY REPORTED ON PRODUCT CODE OTO ASR EXEMPTION # E2014015 FOR APRIL (B)(6), 2019. THIS MDR IS TO REFLECT THE ADDITIONAL INFORMATION TO BE ADDED TO THE INTIAL ASR REPORT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION, AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, INDICATED UTI, DEHISCENCE, RECTAL BLEEDING, PROLAPSE, FISTULA. ON (B)(6) 2017, PORTION OF MESH REMOVED. ON (B)(6) 2018, PORTION OF MESH REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520743 RESTORELLE Y SHAPED 27X4CM SURGICAL MESH OTO COLOPLAST CORP 5014302400 100128-01

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other