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

Catalog Number	0112780
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2013 ¿ patient was diagnosed with direct right inguinal hernia thereby underwent open repair with the implant of perfix plugs (device 1, 2).Per op notes, ¿the inguinal floor appeared to be blown out and there was a large direct hernia sac.The defect was closed by placing two extra large perfix plugs (device 1, 2) in the preperitoneal space and sutured to the edges of the fascial defect.A marlex patch was then placed over the inguinal floor with a hole created for the cord contents and sutured.Nerves were resected.¿ (b)(6) 2018 ¿ patient had recurrent right inguinal hernia thereby underwent revision surgery.(note: there is no op notes provided for this procedure in medical records) attorney alleges abscess, bowel obstruction, infection, pain and suffering.
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-apr-2012) is considered to be a best estimate.This emdr represents the bd perfix plug (device 2).An additional supplemental emdr was submitted to represent the bd 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 ; 8005566756
• MDR Report Key: 24313622
• Report Number: 1213643-2026-00105
• Device Sequence Number: 12181587
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622(17)170428(10)HUWD0438
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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: 04/28/2017
• Device Catalogue Number: 0112780
• Device Lot Number: HUWD0438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2012
• 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 Age: 65 YR
• Patient Sex: Male