BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE L

    MDR report key: 11254791 · Received January 29, 2021

    Report

    Report Number
    2125050-2020-01263
    Event Type
    Injury
    Date Received
    January 29, 2021
    Report Date
    December 11, 2020
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTO
    PMA / PMN Number
    K122440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT IS NOT REQUIRED FOR THIS COMPLAINT AS NO DEVICE WAS RETURNED FOR EVALUATION AND THERE IS NO ADDITIONAL INFORMATION TO REPORT. BASED ON THE AVAILABLE INFORMATION, THE REPORTED COMPLAINT IS IDENTIFIED IN THE RISK MANAGEMENT DOCUMENTATION AND REVIEWED ROUTINELY WITH MANAGEMENT TO MONITOR COMPLAINT TRENDS AS PART OF POST MARKET SURVEILLANCE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THOUGH NOT VERIFIED, ABSTRACT ARTICLE: THERE WERE 182 PATIENTS IN THIS STUDY, OF WHICH 123 UNDERWENT A TOTAL VAGINAL HYSTERECTOMY WITH LAPAROSCOPIC SACROCOLPOPEXY (TVH-LSC), AND 59 UNDERWENT A LAPAROSCOPIC PLACEMENT OF SACROCOLPOPEXY MESH AT TIME OF LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY (LSH-LSC) BETWEEN JUNE 2008 AND JULY 2012. TWO PATIENTS EXPERIENCED MESH EXPOSURE AT THE VAGINAL APEX, MANAGED BY EXCISION IN THE OPERATING ROOM; 1 PATIENT EXPERIENCED EXPOSURE OF THE POSTERIOR VAGINAL WALL WHICH WAS MANAGED BY MESH EXCISION. RATE OF SUTURE EROSION: (1% TVH-LSC VS 2% LSH-LSC, P=1). GRANULATION TISSUE RATE: (10% TVH-LSC VS 7% LSH-LSC, P=0.6), WHICH EXCEPT FOR 1 PATIENT REQUIRING SURGERY, IT WAS MANAGED IN THE OFFICE. ONE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN AND BOWEL OBSTRUCTION. CONCLUSIONS: THERE WAS NO DIFFERENCE IN MESH-RELATED COMPLICATIONS BETWEEN GROUPS (1.6%TVH-LSC VS 1.7%LSH-LSC; P = 1.0). VAGINAL MESH ATTACHMENT DURING TVH-LSC DECREASED OPERATIVE TIME BY OVER 1 HOUR WITH NO DIFFERENCES IN INTRAOPERATIVE COMPLICATIONS, REOPERATION FOR RECURRENT PROLAPSE, AND SUBJECTIVE OR OBJECTIVE OUTCOMES COMPARED TO LSH-LSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149070 RESTORELLE L SURGICAL MESH OTO COLOPLAST A/S 5014402400

    Patients

    Seq Age Sex Outcome Treatment
    1