BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE  Y

    MDR report key: 12774057 · Received November 8, 2021

    Report

    Report Number
    2125050-2021-01632
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    July 14, 2020
    Report Date
    November 8, 2021
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTO
    PMA / PMN Number
    K112322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ARTICLE CITATION: ARMSTRONG, K.L., A.M. MODEST, AND P.L. ROSENBLATT, LAPAROSCOPIC CERCLAGE SACROHYSTEROPEXY: COMPARING A NOVEL TECHNIQUE FOR SACROHYSTEROPEXY TO TRADITIONAL SUPRACERVICAL HYSTERECTOMY AND SACROCERVICOPEXY. FEMALE PELVIC MEDICINE & RECONSTRUCTIVE SURGERY, 2021. 27(2): P. E315-E320. DOI: 10.1097/SPV.0000000000000917 ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS ONE INTRAOPERATIVE COMPLICATION, A BOWEL INJURY, IN THE LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY (LSH) WITH SACROCERVICOPEXY COHORT. THERE WERE 11 POSTOPERATIVE COMPLICATIONS IN THE LHS COHORT. COMPLICATIONS IN THE LSH COHORT INCLUDED 3 WOUND INFECTIONS, 2 PATIENTS WITH A UTI, 2 PATIENTS WITH RECURRENT UTI, 3 PATIENTS WITH GRANULATION TISSUE AND BLEEDING AT THE SITE OF THE POSTERIOR COLPOTOMY, AND 1 PATIENT WITH PERSISTENT PAIN. AT THE 6-WEEK POSTOPERATIVE VISIT, THERE WERE 2 (2.7%) ANATOMIC FAILURES (1 APICAL AND 1 ANTERIOR) IN THE LCSH COHORT AND 3 (3.5%) ANATOMIC FAILURES (ALL APICAL) IN THE LSH WITH SACROCERVICOPEXY COHORT (P = 1.0) POST OPERATIVE COMPLICATIONS INCLUDED PELVIC PAIN, DYSPAREUNIA, WOUND INFECTION, VOIDING DYSFUNCTION, OR BOWEL DYSFUNCTION, HOWEVER, IT WAS UNCLEAR IF THESE PERTAINED TO THE LSH COHORT OR LCSH COHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667509 RESTORELLE  Y SURGICAL MESH OTO COLOPLAST A/S 5014202400

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other