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

Catalog Number	0112760
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	06/16/2009
Type of Reportable Event	Serious Injury
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.This mdr represents the perfix plug (device 2).Additional supplemental emdrs were submitted to represent the perfix plug (device 1), perfix plug (device 4).Perfix plug (device 3) has been created additionally in gcs and updated.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: on (b)(6) 2005 - patient was diagnosed with indirect and direct right inguinal hernia thereby underwent open repair with implant of perfix plugs (device 1, 2.3).Per operation notes, "direct and indirect inguinal hernia was identified in the right inguinal region and was dissected.A large perfix plug (device 1) was placed for the indirect hernia component.Two medium sized perfix plugs (device 2 and 3) were placed in the lateral and medial aspect of the large direct hernia component and sutured.Onlay patch was placed to reinforce the repair and sutured".On (b)(6) 2005- patient was diagnosed with left indirect and direct inguinal hernia, thereby underwent open repair with implant of perfix plugs (device 4, 5).Per operation notes, "a small hernia sac was identified in the left inguinal region and was dissected.A perfix plug (device 4) was placed and sutured.A hernia sac was identified in the area of direct inguinal region and was dissected.A perfix plug (device 5) was placed deep into the peritoneal space and sutured.An onlay patch was then placed to reinforce with tails of patch and sutured".On (b)(6) 2009- patient was diagnosed with recurrent right inguinal hernia and pain, thereby underwent open repair with explant of perfix plugs (device 1,2,3) and implant of bard mesh pre-shaped (device 6).Per operation notes, "significant amount of scar tissue were identified.The external oblique aponeurosis was adherent to the mesh.A lump of mesh was identified and was dissected.The perfix plugs (device 2 and 3) were identified and excised.Medially on the floor, hernia sac was identified and dissected.A bard mesh pre-shaped (device 6) was trimmed, placed on the floor and sutured".

• 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: 24799533
• Report Number: 1213643-2026-00444
• Device Sequence Number: 21318282
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(10)43KND078
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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 Catalogue Number: 0112760
• Device Lot Number: 43KND078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 79 KG