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 Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	03/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2013 - patient was diagnosed with recurrent ventral incisional hernia and left inguinal hernia thereby underwent open recurrent ventral incisional hernia repair with the implant of ventrio mesh (device 1) and left inguinal hernia repair with the implant of perfix plug (device 2).Per op notes, "a midline incision was made, ventrio mesh (device 1) was placed towards the abdominal cavity using prolene sutures.Attention to the left inguinal hernia, where a left incision was performed.A perfix plug (device 2) was placed to the abdomen using sutures." on (b)(6) 2016 - patient was diagnosed with recurrent ventral incisional hernia hereby underwent laparoscopic repair with the removal of both meshes (device 1 and 2) and implant of ventrio st mesh (device 3).Per op notes, "patient had recurrent ventral incisional hernia which had been repaired previously with two meshes.Extensive intra-abdominal adhesions were taken down.The more recent mesh (device 1 and 2) which had been placed appeared to have folded over on itself.Both meshes (device 1 and 2) were removed from the abdominal wall.A ventrio st mesh (device 3) was secured to the old mesh inferiorly using sutures.".
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-mar-2013) 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 ventrio mesh (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: 50078391
• Report Number: 1213643-2026-00969
• Device Sequence Number: 18696902
• Product Code: FTL
• UDI-Device Identifier: 00801741016684
• UDI-Public: (01)00801741016684(17)180428(10)HUXC1509
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 04/28/2018
• Device Catalogue Number: 0112980
• Device Lot Number: HUXC1509
• 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: 07/23/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2013
• 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