MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG; SURGICAL MESH

Catalog Number	0112770
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Fibrosis (3167)
Date of Event	08/15/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2008 ¿ patient was diagnosed with indirect bilateral inguinal hernia thereby underwent open repair with two perfix plug (device #1 and #2).Per operative notes, ¿in the right side, indirect hernia sac was identified and reduced.A large perfix plug (device #1) was placed in the peritoneal space and sutured and tacked in place.Similarly in left side, large indirect sac was reduced and large perfix plug (device #2) was placed in preperitoneal space and secured in place with sutures.¿ (b)(6) 2012 - patient was diagnosed with bilateral inguinodynia and recurrent right inguinal hernia thereby underwent open repair with removal of all meshes, neurectomy and implant of bard soft mesh pre-shaped w/keyhole on both sides (device #3 and #4).Per operative notes, ¿in right side, extensive dense sclerotic fibrosis and scarring within inguinal canal was noted.The genitofemoral nerve was identified and transected.The mesh (device #1) was seen densely adherent and removed.A large indirect defect with internal ring defect was identified and large bard soft mesh pre-shaped w/keyhole (device #3) was placed and secured with sutures.In left side, fibrosis was noted.The ilioinguinal, iliohypogastric and genitofemoral nerves were transected, and mesh (device #2) was less adherent and removed.The floor was reconstructed, and bard soft mesh pre-shaped w/keyhole (device #4) was placed and secured with sutures.¿.
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-jul-2008) is considered to be a best estimate.This emdr was submitted to represent the bard/davol perfix plug (device #2).Additional supplemental emdr represents the bard/davol 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.

• Brand Name: PERFIX PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 22714546
• Report Number: 1213643-2025-00717
• Device Sequence Number: 9628075
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)130728(10)HUSG0510
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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: 07/28/2013
• Device Catalogue Number: 0112770
• Device Lot Number: HUSG0510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2008
• 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: Disability; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male