MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 3INX6IN; MESH, SURGICAL, POLYMERIC

Model Number SPMII

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2006 and mesh was implanted.It was reported that following the procedure the patient experienced abdominal pain, pelvic pain, infections, bowel problems, recurrence of pelvic organ prolapse, recurrence of stress urinary incontinence.No additional information was provided.

Manufacturer Narrative

This emdr represents supplemental report # 2210968-2017-31131 for previously submitted mdr number 2210968-2017-31336, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective (b)(6) 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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.The information included in this report was submitted outside the required timeframe due to the extended use of exemption e2013037 beyond its revoke date, as documented under (b)(4) (ethicon¿s internal reference number).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.

• Brand Name: PROLENE SOFT MESH 3INX6IN
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12716489
• MDR Text Key: 284545844
• Report Number: 2210968-2021-09506
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031050471
• UDI-Public: 10705031050471
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SPMII
• Device Catalogue Number: SPMII
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1