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

Catalog Number	3DPL1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Paresthesia (4421)
Date of Event	06/19/2007
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unspecified procedure on (b)(6) 2007 and mesh was implanted.The patient reported experiencing chronic pain, discomfort, pain when walking and bending, tingling and pulling sensations.No further information could be obtained due to lack of contact information.
Additional Manufacturer Narrative
Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D4: udi: as the catalog/model number was not provided, the (01)gtin is not available.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: d4, gi manufacturing site corrected information: d1, g4 additional information was requested, and the following was obtained: chronic pain, discomfort.Pain when walking, bending, tingling, pulling sensations.Event description : following the operation: severe pain, a stabbing pain at the site of the hernia, chronic fatigue.Difficulty walking.Unable to lie on my side.Pain when touching the hernia area.Difficulty putting on clothing.Difficulty bending over.----------------- impacted product : product code : 13422-07 lot number : 3dpl1 additional information from user report: bilateral inguinal hernia repair with placement of a 3d prosthetic patch from ethicon.Date of occurrence: (b)(6) 007.

• Brand Name: PRLNE 3D PATCH LG DIAMOND (5CM)
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): J-PAC; 25 centre rd; p.o. box 1409; somersworth NH 03878
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22003947
• Report Number: 2210968-2025-05224
• Device Sequence Number: 7266611
• Product Code: FTL
• UDI-Device Identifier: 10705031005143
• UDI-Public: (01)10705031005143(17)090731(10)13422-07
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K010722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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 Catalogue Number: 3DPL1
• Device Lot Number: 13422-07
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2004
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown