BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 3113438 · Received May 15, 2013

    Report

    Report Number
    2210968-2013-05548
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO PELVIC ORGAN PROLAPSE.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REPORTED THAT THE PATIENT UNDERWENT EXPLORATION OF VAGINAL INCISION FROM PREVIOUS SURGERY WITH CAUTERIZATION OF BLEEDING POINTS AND RECLOSURE OF THE INCISION ON (B)(6) 2014 BY DR. (B)(6) DUE TO VAGINAL HEMATOMA WITH BLEEDING THAT WAS DETECTED IN POSTOPERATIVE RECOVERY AT THE MOBILE INFIRMARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DETAILS: IT HAS BEEN REPORTED THAT THE PATIENT UNDERWENT EXPLORATION OF VAGINAL INCISION FROM PREVIOUS SURGERY TODAY WITH CAUTERIZATION OF BLEEDING POINTS AND RECLOSURE OF THE INCISION ON (B)(6) 2014 BY DR. (B)(6) DUE TO VAGINAL HEMATOMA WITH BLEEDING THAT WAS DETECTED IN POSTOPERATIVE RECOVERY AT THE MOBILE INFIRMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214180 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3475444

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention