MAUDE Adverse Event Report: ETHICON INC. PROLENE SOFT MESH 6INX6IN; MESH, SURGICAL, POLYMERIC

Model Number	SPMH
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This emdr represents supplemental report #2210968-2017-32831 for previously submitted mdr number 2210968-2017-32099 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 the referenced exemption was revoked effective may 15, 2019.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.(b)(4) submitted for adverse event which occurred on (b)(6) 2016.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.
Event or Problem Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and mesh was implanted concurrently with laparoscopic sacrocolpoperineopexy with graft extension, laparoscopic right salpingo-oophorectomy, laparoscopic enterocele repair, rectocele repair with pelvicol graft, perineoplasty and cystoscopy.It was reported that the patient underwent a revision surgeries on (b)(6) 2016, (b)(6) 2017, (b)(6) 2018 and on (b)(6) 2018.No additional information was provided.

• Brand Name: PROLENE SOFT MESH 6INX6IN
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12680355
• Report Number: 2210968-2021-10178
• Device Sequence Number: 1232079
• Product Code: FTL
• UDI-Device Identifier: 10705031050464
• UDI-Public: 10705031050464
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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: 07/31/2015
• Device Model Number: SPMH
• Device Catalogue Number: SPMH
• Device Lot Number: CLB523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR