MAUDE Adverse Event Report: ETHICON INC. PRLNE 3D PATCH LG DIAMOND (5CM); MESH, SURGICAL, POLYMERIC

Model Number	P3DPL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 or Problem Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent surgery on (b)(6) 2018 to remove a painful mass during which the surgeon noted the mass had the appearance of a balled up pieced of mesh and that the mass was likely the portion of mesh overlapping the pubic tubercle.It was reported that the patient experienced severe pain in her left groin.No additional information is provided.
Additional Manufacturer Narrative
Date sent to the fda: 2/21/2021.Additional information: a2, d6b.Additional b5 narrative: it was reported that the patient underwent mesh removal surgery on (b)(6) 2018.

• Brand Name: PRLNE 3D PATCH LG DIAMOND (5CM)
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10181683
• Report Number: 2210968-2020-04657
• Device Sequence Number: 19368946
• Product Code: FTL
• UDI-Device Identifier: 10705031047501
• UDI-Public: 10705031047501
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K010722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• 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): 06/19/2020

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: 01/31/2017
• Device Model Number: P3DPL
• Device Catalogue Number: P3DPL
• Device Lot Number: 24938-08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 02/21/2021
• 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