MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 2.5INX4.5IN; MESH, SURGICAL, POLYMERIC

Model Number	SPMS
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2017-70668, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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 or Problem Description
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and prolene was implanted.It was reported that the patient experienced pain and erosion of her internal bodily tissue.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 4/3/2022.Additional b5 narrative: it was reported that the patient underwent mesh removal on (b)(6) 2010 due to recurrent stress incontinence.

• Brand Name: PROLENE SOFT MESH 2.5INX4.5IN
• Common Device Name: 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; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan 08869
• MDR Report Key: 12741400
• Report Number: 2210968-2021-10697
• Device Sequence Number: 4239201
• Product Code: FTL
• UDI-Device Identifier: 10705031050495
• UDI-Public: 10705031050495
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2012
• Device Model Number: SPMS
• Device Catalogue Number: SPMS
• Device Lot Number: ZHE931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 04/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female