BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 4886030 · Received July 1, 2015

    Report

    Report Number
    2183959-2015-00287
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    May 27, 2015
    Report Date
    June 2, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AGAINST AN INITIAL REPORT THAT WAS SUBMITTED UNDER THE PREVIOUS SITE REGISTRATION NUMBER ((B)(4)). THE EFFECTIVE SITE REGISTRATION NUMBER IS (B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE ANTERIOR GRAFT THE PATIENT EXPERIENCED MILD DE-NOVO DIFFICULTY EMPTYING BLADDER. SHE WAS "SENT HOME FROM HOSPITAL WITH A FOLEY CATHETER ." ON (B)(6) 2015 THE PHYSICIAN "FILLED BLADDER W/ 300CC THEN PVR 369. SECOND VOID 24CC THEN PVR 369. I&O CATH 420CC." THE FOLEY WAS REPLACED AND FOLLOW-UP WAS TO OCCUR IN TWO DAYS. THE EVENT WAS CONSIDERED RECOVERING/RESOLVING (ADVERSE EVENT IS IMPROVING). THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD A "FILL AND PULL" WITH "PVR 353" ON (B)(6) 2015, AND THE FOLEY WAS REPLACED. IT WAS THEN REPORTED ON (B)(6) 2015 THE PATIENT EXPERIENCED "WAS LOW PRESSURE LOW FLOW" AND " NO OBSTRUCTION". THE PATIENT WAS THEN INSTRUCTED TO "HOME CIC". ON (B)(6) 2015 THE PATIENT RECEIVED A PELVIC "US". THE PATIENT THEN EXPERIENCED "SP CATH STABLE" AND THE PATIENT CONTINUED "SPONTANEOUS VOIDS AND CHECK RESIDUALS WITH CATHETERN 06/16/2015. ON (B)(6) 2015 THE PATIENT CONTINUED "VOIDING SPONTANEOUSLY" AND HAD "RESIDUALS STILL HIGH". THE PATIENT WAS INSTRUCTED TO "CONTINUE SP". THE PATIENT THEN FOLLOWED UP AND THE VOIDING THEN "IMPROVED" WITH RESIDUALS "LESS THAN 200." THE VOIDING CONTINUED TO IMPROVE AND THE PATIENT THEN HAD A "REMOVAL OF SP CATHETER". THE EVENT IS CONSIDERED RESOLVED/RECOVERED WITH NO SEQUELAE ON (B)(6) 2015. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE MACROBID (100 MG DAILY TO PREVENT UTI) WAS STARTED ON (B)(6) 2015. THE EVENT WAS STILL CONSIDERED TO BE RECOVERING/RESOLVING. NO FURTHER COMPLICATIONS WERE REPORTED RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD A "VAGINAL APICAL MESH REVISION SURGERY" ON (B)(6) 2015. THE MESH WAS TRIMMED AND PARTIALLY EXPLANTED. IT WAS NOTED THAT THE PATIENT EXPERIENCED "MESH EXPOSURE". THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424365 AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R