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

Catalog Number SPMLI34

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Purulent Discharge (1812); Micturition Urgency (1871); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This emdr represents supplemental report #2210968-2017-30584 for previously submitted mdr number 2210968-2017-30283.Subject of a litigation complaint summary exemption no. e2013037. the referenced exemption was revoked effective may 15, 2019. 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).(b)(4).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 by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and mesh was implanted.It was reported that the patient experienced urinary frequency, urgency, dysuria, urinary tract infections, vaginal discharge, apex of vagina, granulation tissue, yellow, white purulent material and green vaginal discharge.It was reported that the patient underwent removal surgery of vaginal cuff, granulation tissue on (b)(6) 2016.It was reported that the patient experienced vaginal discharge, pelvic abscess and infection on (b)(6) 2016.It was reported that the patient died on (b)(6) 2016.No additional information was provided.

• Brand Name: PROLENE SOFT MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12678023
• MDR Text Key: 281223114
• Report Number: 2210968-2021-10140
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/21/2021

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: 01/31/2016
• Device Catalogue Number: SPMLI34
• Device Lot Number: DGH013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR