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	08/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2016 - patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1).Per op notes, ¿a perfix plug (device #1) was placed into the inguinal hernia defect and was secured with prolene sutures." (b)(6) 2017 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #2).Per op notes, ¿there was a direct inguinal hernia noted and was reduced.A perfix plug (device #2) was placed into the hernia defect and a patch was also placed over the plug using prolene sutures.¿ (note: a perfix plug (device #1) was not seen during this procedure).(b)(6) 2017 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of perfix plug (device #3).Per op notes, ¿a small perfix plug (device #3) was placed overlying the inguinal canal using prolene suture & a patch was placed over the plug.¿ (note: a perfix plug (device #2) was not seen during this procedure).(b)(6) 2018 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the removal of mesh (device #2 & #3).Per op notes, ¿there were two pieces of mesh (device #2 & #3) lying in the subcutaneous tissue superficial to the external oblique fascia.Both pieces were discarded.A synthetic mesh was placed.¿ (b)(6) 2020 - patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with the removal of mesh (device #1).Per op notes, ¿the mesh (device #1) had come loose through which the cord exited was enlarged and allowed for the recurrent indirect hernia.The prior mesh (device #1) was removed.A synthetic mesh was placed.¿.
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 bard/davol perfix plug (device #1).An additional supplemental emdr was submitted to represent the bard/davol perfix plug (device #2 and device #3).Note, the manufacturing date (15-nov-2015) is considered to be a best estimate.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: 22158407
• Report Number: 1213643-2025-00433
• Device Sequence Number: 15663876
• Product Code: FTL
• UDI-Device Identifier: 00801741016608
• UDI-Public: (01)00801741016608(17)201028(10)HUZK1106
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• 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: 10/28/2020
• Device Catalogue Number: 0112760
• Device Lot Number: HUZK1106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2015
• 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: 71 YR
• Patient Sex: Male