MAUDE Adverse Event Report: ETHICON INC. PROLENE 3D PATCH MED DIAM (3.5CM), EXT; MESH, SURGICAL, POLYMERIC

Model Number	P3DPM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scarring (2061); Hernia (2240)
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.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
Event or Problem Description
It was reported by an attorney that the patient underwent inguinal hernia repair surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient had removal surgery on (b)(6) 2010 during which the surgeon noted: "one major and one minor nerve trunk, all of which were trapped in a mass of mesh and scar.The surgeon commenced a very difficult and tedious dissection and was able to fully extract up toward the portion of the material from within the retroperitoneal space.The surgeon identified a recurrence or persistence of an indirect inguinal hernia sac in the course of his retroperitoneal dissection.The base of the residual sac was suture ligated, then was amputated.The surgeon mobilized all of the mesh from its lateral fixation points long the inguinal ligament.The most tedious aspect of the dissection was trying to separate the cord and its contents from the mesh.The cord was actually caught between the plug and the anterior mesh leaflet had created a tunnel-like effect around the spermatic cord." it was reported that the patient experienced severe pain, inflammation, sexual dysfunction and nerve block treatments.No additional information is provided.
Additional Manufacturer Narrative
Date sent to the fda: 02/25/2020.Additional information: d3,g1,g2, g5.Corrected information: g1.
Additional Manufacturer Narrative
Date sent to the fda: 01/11/2022.Additional information: a2, d3, g1.

• Brand Name: PROLENE 3D PATCH MED DIAM (3.5CM), EXT
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876 0151
• Manufacturer (Section G): J-PAC; 25 centre road; nh; somersworth 03878 0151
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08876-0151 ; 6107428552
• MDR Report Key: 8253312
• Report Number: 2210968-2019-78409
• Device Sequence Number: 16691817
• Product Code: FTL
• UDI-Device Identifier: 10705031047525
• UDI-Public: 10705031047525
• Combination Product (Y/N): N
• PMA/510(K) Number: K061533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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,Followup
• Report Date (Section B): 01/14/2019

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: 01/31/2018
• Device Model Number: P3DPM
• Device Catalogue Number: P3DPM10
• Device Lot Number: 19220-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/24/2020; 01/09/2022
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/25/2020; 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2008
• 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 Sex: Male