MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUG; SURGICAL MESH

Catalog Number	0112770
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Pain (1994)
Date of Event	12/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the additional information received, there is no change to initial determination, no conclusions can be made.About 6 years 8 months post implant of perfix plug, patient was diagnosed with nerve damage, adhesions, pain and migration.The instructions-for-use supplied with the device list adhesions as a possible complication.Note, the manufacturing date (15-oct-2008) is considered to be a best estimate.This emdr represents the perfix plug (device #2).An additional supplemental emdr was submitted to represent the perfix plug (device #1).Note: section a through f: the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
Per information provided: (b)(6) 2009: patient had bilateral inguinal hernia, thereby underwent repair with the implant of two perfix plug.(b)(6) 2015: patient had exploration of groin and lysis of adhesion.Attorney alleges that the patient had adhesion, mesh migration, mesh was not able to be removed, pain and suffering.It is also alleged that the patient suffered from chronic pain has limited his mobility in his employment as a mechanic as well as in his activities of daily life.Plaintiff believes that he may have nerve damage due to the mesh and is in a pain management program attempting to relive his pain.

• Brand Name: PERFIX PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 21420674
• Report Number: 1213643-2025-090093
• Device Sequence Number: 7987098
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)131128(10)HUSJ1504
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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: 11/28/2013
• Device Catalogue Number: 0112770
• Device Lot Number: HUSJ1504
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2008
• 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 Age: 53 YR
• Patient Sex: Male