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	Pain (1994); Scar Tissue (2060); Hernia (2240)
Date of Event	09/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2011 - patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of perfix plug (device 1).Per op notes, "a medium perfix plug and patch (device 1) was placed over the inguinal floor using prolene sutures." (b)(6) 2013 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of perfix plug (device 2).Per op notes, "a medium perfix plug (device 2) was placed at the pubic tubercle of poupart's ligament using prolene sutures." (b)(6) 2017 - patient was diagnosed with recurrent right inguinal hernia thereby underwent repair.Per op notes, "an incision was made through the existing scar.There was mesh (device 1) on the floor of the inguinal canal that was crumpled up.Between 2 folds of the mesh as the hernia defect." (b)(6) 2019 - patient had right groin pain and was diagnosed with recurrent left inguinal hernia thereby underwent repair wit removal of mesh (device 1 and 2).Per op notes, "attention to the left side, the perfix plug (device 2) was removed and placed a 3dmax mesh (device 3) into the preperitoneal space using tacks.Attention the right side, perfix plug (device 1) was removed and placed a right-sided 3dmax mesh (device 4) into the preperitoneal space using tacks.".
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-nov-2010) is considered to be a best estimate.This emdr represents the bd perfix plug (device 1).An additional supplemental emdr was submitted to represent the bd perfix plug (device 2).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: 23484863
• Report Number: 1213643-2025-01072
• Device Sequence Number: 16075813
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(17)151128(10)HUUK0384
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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: 11/28/2015
• Device Catalogue Number: 0112760
• Device Lot Number: HUUK0384
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2010
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 83 KG