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

Catalog Number	0112980
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/27/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2013- patient was diagnosed with recurrent right inguinal hernia, left inguinal hernia, thereby underwent open repair with implant of perfix plugs (device 1 and 2).Per op notes, "in the right inguinal region, previously placed mesh was found pulled away and there was hernia with omentum.The omentum was reduced an dwas repaired by placing perfix plug (device 1) and sutured.Then on the left inguinal region, direct hernia was identified and was dissected.An extra large perfix plug (device 2) was placed and sutured." (b)(6) 2016- patient was diagnosed with recurrent bilateral inguinal hernias, thereby underwent robotic repair with implant of synthetic mesh.Per op notes, "some adhesions in the right inguinal area along with indirect hernia was identified.There was a recurrent direct hernia and the perfix plug (device 1) was found pulled away from pubic tubercle area.A synthetic mesh was placed covering the entire inguinal canal and sutured.There was a large piece of mesh (perfix plug-device 2) was found crumpled up and stuck to the spermatic cord.There was a recurrent indirect hernia.Another synthetic mesh was then placed and sutured.".
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-jun-2012) 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.

• 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: 50427833
• Report Number: 1213643-2026-01086
• Device Sequence Number: 13356662
• Product Code: FTL
• UDI-Device Identifier: 00801741016684
• UDI-Public: (01)00801741016684(17)170628(10)HUWF1059
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: 06/28/2017
• Device Catalogue Number: 0112980
• Device Lot Number: HUWF1059
• 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: 08/12/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2012
• 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