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

Catalog Number	0112970
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	04/16/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2005 ¿ patient was diagnosed with bilateral inguinal hernia and umbilical hernia thereby underwent open repair with implant of four perfix plugs (device 1, 2, 3 and 4) and ventralex mesh (device 5).Per operative notes, ¿in the right groin, large sized direct inguinal hernia was dissected free from fascia and two large perfix plugs (device 1 and 2) was placed and sutured in position.On left side, identical procedure was followed and another two large perfix plug mesh (device 3 and 4) was placed.In umbilical hernia, hernia sac in infraumbilical area was dissected and ventralex mesh (device 5) was placed and sutured.¿ (b)(6) 2008 ¿ patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with removal of mesh (device 1 and 2) and implant of synthetic mesh.Per operative notes, ¿significant scarring with large medial hernia defect was identified.The mesh (device 1 and 2) was dissected free from the cord structures and recurrent hernia was closed and synthetic mesh was placed and sutured.¿ (b)(6) 2009 ¿ patient was diagnosed with recurrent bilateral inguinal hernia thereby underwent laparoscopic repair with implant of two large 3dmax meshes (device 6 and 7).Per operative notes, ¿a recurrent bilateral direct defect was reduced and two large 3dmax meshes (device 6 and 7) was placed on both sides covering the defects and sutured.¿ (b)(6) 2016 ¿ patient was diagnosed with recurrent right inguinal hernia and right groin pain thereby underwent open repair with implant of bard flat mesh (device 8).Per operative notes, ¿a mesh (device 6) was seen migrated and direct recurrent right inguinal hernia was reduced and bard flat mesh (device 8) 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.This emdr represents the bd perfix plug (device 3).Additional supplemental emdrs and emdrs were submitted to represent the other bd devices.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: 23412877
• Report Number: 1213643-2025-01033
• Device Sequence Number: 8945390
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677(10)43COD142
• 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: 2005
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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 Catalogue Number: 0112970
• Device Lot Number: 43COD142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/29/2025
• 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: 44 YR
• Patient Sex: Male