BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPRIS SUPRAPUBIC SURGIC

    MDR report key: 7131105 · Received December 19, 2017

    Report

    Report Number
    2125050-2017-00631
    Event Type
    Injury
    Date Received
    December 19, 2017
    Report Date
    December 20, 2017
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTN
    PMA / PMN Number
    K111233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT THE CORRECTED MEDWATCH NUMBER (5073266).

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION ON MEDWATCH MW507266 - PATIENT HAD A TVT MESH SLING IMPLANTED FROM COLOPLAST WHICH MAKES SEXUAL INTERCOURSE IMPOSSIBLE, IRRITABLE BOWEL SYNDROME, VERY TIRED, OVERFLOW INCONTINENCE - MUST USE A CATHETER, PERMANENT INFECTION.

    Description of Event or Problem · 1

    MEDWATCH (B)(4) - PATIENT HAD A TVT MESH SLING IMPLANTED FROM COLOPLAST WHICH MAKES SEXUAL INTERCOURSE IMPOSSIBLE, IRRITABLE BOWEL SYNDROME, VERY TIRED, OVERFLOW INCONTINENCE - MUST USE A CATHETER, PERMANENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907773 SUPRIS SUPRAPUBIC SURGIC SURGICAL MESH OTN COLOPLAST A/S 5195601000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other