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

Catalog Number	0112760
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/15/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2007 - patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of perfix plug (device #1 & #2).Per operative notes, ¿the direct hernia sac was identified and dissected.A large perfix plug (device #1) was placed and tacked.The prolapsing cord lipoma was dissected.A medium size perfix plug (device #2) was placed and tacked.¿ (b)(6) 2009 - patient was diagnosed with recurrent left inguinal hernia with pain thereby underwent open repair with implant perfix plug (device #3).Per operative notes, ¿moderate amount of scar tissue was excised.The defect was identified and dissected.A perfix plug (device #3) was placed with onlay mesh and tacked to pubic tubercle.¿ (b)(6) 2016 - patient was diagnosed with recurrent left inguinal hernia thereby underwent laparoscopic repair with implant of bard flat mesh (device #4).Per operative notes, ¿the hernia sac was identified and reduced.A bard flat mesh (device #4) was placed and tacked.".
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-sep-2008) is considered to be a best estimate.This emdr represents the perfix plug (device #3).An additional supplemental emdr and an emdr were submitted to represent the perfix plug (device #1 & #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: 22129959
• Report Number: 1213643-2025-00418
• Device Sequence Number: 15555662
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(17)130928(10)HUSI0491
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/26/2025

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: 09/28/2013
• Device Catalogue Number: 0112760
• Device Lot Number: HUSI0491
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2008
• 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: 62 YR
• Patient Sex: Male