BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFFRON ANCHOR

    MDR report key: 17632597 · Received August 28, 2023

    Report

    Report Number
    2125050-2023-01043
    Event Type
    Injury
    Date Received
    August 28, 2023
    Report Date
    August 28, 2023
    Manufacturer
    COLOPLAST A/S
    Product Code
    PBQ
    PMA / PMN Number
    K220420
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS 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

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REQUIRED EXPLANTATION DUE TO PAIN. THE PATIENT REPORTED RIGHT SIDE BUTTOCK PAIN. THE SACROSPINOUS SUTURE WAS RELEASED AND THE ANCHORS WERE EXPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338347 SAFFRON ANCHOR SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE PBQ COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown Required Intervention