MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 PerFix Plug; Surgical Mesh

Catalog Number	0112770
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	04/19/2018
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.Note, the manufacturing date (15-feb-2015) is considered to be a best estimate.This emdr represents the bard perfix plug (device 2).An additional supplemental emdr was submitted to represent the bard perfix plug (device 1).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 23-sep-2015 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of perfix plug (device 1 and 2).Per op notes, "on the right inguinal region, an indirect and a large direct hernia sac were noted and separated from the cord structures.A perfix plug (device 1) with onlay patch was placed and sutured.On the left inguinal region, large direct and indirect hernia defects were noted and reduced.A perfix plug (device 2) with onlay patch was placed and sutured." on (b)(6) 2018 - patient was diagnosed with chronic bilateral groin pain thereby underwent open repair with excision of perfix plug (device 1 and 2).Per op notes, "on the right inguinal region, the cord structures were densely adherent to the old mesh (device 1) were taken down.The cord structures were mobilized.The old mesh (device 1) was excised and removed.On the left inguinal region, the mesh (device 2) was densely adherent to the cord structures were taken down.The old mesh (device 2) was excised and removed.Both defects on right and left inguinal region were closed with sutures.".

• 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 ; +1(800)556-6756
• MDR Report Key: 50588123
• Report Number: 1213643-2026-01152
• Device Sequence Number: 21195078
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)200128(10)HUZB0529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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 Expiration Date: 01/28/2020
• Device Catalogue Number: 0112770
• Device Lot Number: HUZB0529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2015
• 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 Sex: Male