BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE L

    MDR report key: 10977134 · Received December 9, 2020

    Report

    Report Number
    2125050-2020-01236
    Event Type
    Injury
    Date Received
    December 9, 2020
    Report Date
    December 9, 2020
    Manufacturer
    COLOPLAST A/S
    Product Code
    OTO
    PMA / PMN Number
    K122440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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 OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    GURLAND B, E CARVALHO MEC, RIDGEWAY B, PARAISO MFR, HULL T, ZUTSHI M. SHOULD WE OFFER VENTRAL RECTOPEXY TO PATIENTS WITH RECURRENT EXTERNAL RECTAL PROLAPSE? INT J COLORECTAL DIS. 2017 NOV;32(11):1561-1567. DOI: 10.1007/S00384-017-2858-9. EPUB 2017 AUG 7. PMID: 28785819. ACCORDING TO THE AVAILABLE INFORMATION, OF 108 PATIENTS, ONE EXPERIENCED DISCITIS, FIVE EXPERIENCED ILEUS, TWO HAD MAJOR BLEEDING, TWO HAD PELVIC ABSCESS, TWO HAD PELVIC COLLECTION, SEVEN WERE READMITTED, ONE EXPERIENCED RECTAL-VAGINAL FISTULA, THREE UNDERWENT REOPERATION, THREE HAD SMALL BOWEL OBSTRUCTION, FOUR HAD WOUND INFECTION, 22 HAD MEDICAL COMPLICATIONS, ONE EXPERIENCED SEPSIS, FOUR HAD URINARY INFECTIONS, FOUR HAD "CARDIOPULMONARY" AND FIVE EXPERIENCED A VENOUS THROMBOTIC EVENT. SIXTEEN RECURRENCES OF PROLAPSE OCCURRED, 11 OF WHICH HAD FULL THICKNESS RECTAL PROLAPSE AND WERE TREATED WITH ADDITIONAL PROLAPSE SURGERY. SYMPTOMATIC MUCOSAL PROLAPSE WAS NOTED IN FIVE PATIENTS, THREE OF WHICH WERE TREATED WITH DELORME WHILE THE OTHER TWO DEFERRED TREATMENT. IT WAS UNCLEAR WHICH, IF ANY, OF THE COMPLICATIONS COULD HAVE BEEN ATTRIBUTED TO USE OF RESTORELLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439822 RESTORELLE L SURGICAL MESH OTO COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R