MAUDE Adverse Event Report: ETHICON INC. POSTERIOR PELVIC FLOOR REPAIR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRP01

Device Problem Migration (4003)

Patient Problems Adhesion(s) (1695); Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Fibrosis (3167)

Event Type  Injury  

Manufacturer Narrative

This emdr represents supplemental report # 2210968-2017-01154 for previously submitted mdr number 2210968-2017-01655, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and prolift was implanted.It was reported that the patient experienced mixed incontinence, dyspareunia, difficulty voiding, dysuria, frequency, nocturia, urinary tract infections and urgency.It was reported that the patient experienced pain, infection, vaginal mesh erosion with fibrosis following the procedure.It was reported that the patient underwent multiple revision surgeries.It was reported that the patient underwent excision of vaginal mesh with lysis of adhesion and vaginal cuff reconstruction on (b)(6) 2016.No additional information was provided.

• Brand Name: POSTERIOR PELVIC FLOOR REPAIR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan 08869
• MDR Report Key: 12777213
• MDR Text Key: 285228246
• Report Number: 2210968-2021-11079
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2011
• Device Catalogue Number: PFRP01
• Device Lot Number: 3157282
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female