ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
|
Back to Search Results |
|
Catalog Number PROLIFTUNK |
Device Problem
Migration (4003)
|
Patient Problems
Erosion (1750); Fistula (1862); Pain (1994)
|
Event Type
Injury
|
Manufacturer Narrative
|
This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2018-75203, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
|
|
Event Description
|
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and prolift was implanted.It was reported that she experienced pain, dysuria, erosion of her internal bodily tissue and other injuries following the procedure.She had surgery on (b)(6) 2017, related to the mesh.It was reported that the patient underwent excision surgery on (b)(6) 2016.It was reported that the patient experienced pain and vesicovaginal fistulas which required vaginal sling repairs on (b)(6) 2018.No additional information was provided.
|
|
Search Alerts/Recalls
|
|
|