MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 10INX10IN; MESH, SURGICAL, POLYMERIC

Model Number	SPMLI
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2005 and prolene was implanted.It was reported that the patient experienced severe pelvic pain.It was reported that the patient underwent a revision surgery on an unknown date.No additional information was provided.
Additional Manufacturer Narrative
This emdr represents supplemental report # 2210968-2017-30623 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mdr number 2210968-2017-30283, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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.
Additional Manufacturer Narrative
Date sent to the fda: 4/6/2022.
Additional Manufacturer Narrative
Date sent to the fda: 4/19/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PROLENE SOFT MESH 10INX10IN
• 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; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan 08869
• MDR Report Key: 12777076
• Report Number: 2210968-2021-11064
• Device Sequence Number: 19743836
• Product Code: FTL
• UDI-Device Identifier: 10705031050488
• UDI-Public: 10705031050488
• 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: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2009
• Device Model Number: SPMLI
• Device Catalogue Number: SPMLI
• Device Lot Number: TJB842
• 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: 03/17/2021
• Supplement Date Received by Manufacturer: 04/06/2022; 04/14/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 04/06/2022; 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2004
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female