|
Catalog Number 810081 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Micturition Urgency (1871); Incontinence (1928); Pain (1994); Ambulation Difficulties (2544)
|
Event Date 01/01/2018 |
Event Type
Injury
|
Event Description
|
It was reported that a patient underwent a sling procedure in 2016 and mesh was implanted.Beginning in 2018, the patient experienced severe pain in the pelvic floor, vagina, right pubis, right obturator muscle, right adductor muscle and right groin along with urinary leakage with urgency, decreased mobility, pain with walking, sitting, standing and laying and dyspareunia.These symptoms were over the course of 7 years.Some symptoms have resolved with the removal of the implant on (b)(6) 2023.Additional information has been requested.
|
|
Manufacturer Narrative
|
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
|
|
Search Alerts/Recalls
|
|
|