MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC

Model Number PML

Device Problem Migration (4003)

Patient Problems Autoimmune Disorder (1732); Erosion (1750); Micturition Urgency (1871); Urinary Retention (2119); Urinary Frequency (2275); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2002 and mesh was implanted. It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2003 and b-uretex was implanted. It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure. It was reported that the patient experienced abdominal swelling and auto immune disorder following the procedure. It was reported that the patient has undergone multiple surgeries and revisionary procedures. No additional information was provided.

Manufacturer Narrative

This emdr represents supplemental report # 2210968-2017-04521 for previously submitted mdr number 2210968-2017-70664, 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 The referenced exemption was revoked effective may 15, 2019.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.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; 00754 PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan 08869
• MDR Report Key: 12876241
• MDR Text Key: 285748832
• Report Number: 2210968-2021-12115
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031049031
• UDI-Public: 10705031049031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2006
• Device Model Number: PML
• Device Catalogue Number: PML
• Device Lot Number: QME748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/25/2021 Patient Sequence Number: 1