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

Catalog Number	0112750
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	10/11/2018
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-mar-2014) is considered to be a best estimate.This mdr represents the perfix plug (device 2).An additional supplemental emdr was submitted to represent the 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: (b)(6) 2014 ¿ patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of two perfix plug meshes (device 1 and 2).Per operative notes, ¿in the right side, the hernia sac was lateral to the rectus muscle and sac was pushed back on the fascial margins.A small perfix plug (device 1) was placed and secured to the ring with sutures.In the left side, the hernial defect was reduced from the inguinal canal lateral to the pubic tubercle.The sac was inverted and another small size perfix plug (device 2) was placed and secured to fascial edges with sutures.¿ (b)(6) 2018 ¿ patient was diagnosed with recurrent bilateral inguinal hernia and painful mesh plug (device 1 and 2) thereby underwent open repair with resection of prior meshes (device 1 and 2) and implant of synthetic mesh.Per operative notes, ¿a large recurrent bilateral inguinal hernias were noted.Both mesh plugs (device 1 and 2) were resected by existing from all adjacent structures.The large hernia sac on the right side was resected, and small left side sac was imbricated with sutures.A synthetic mesh was placed over the inguinal canal and sutured.The extensive adhesions from prior repairs were lysed, flaps were raised and fascia was closed.¿.

• 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: 24326901
• Report Number: 1213643-2026-00122
• Device Sequence Number: 15833546
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592(17)190328(10)HUYC0248
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 01/23/2026

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: 03/28/2019
• Device Catalogue Number: 0112750
• Device Lot Number: HUYC0248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2014
• 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: 46 YR
• Patient Sex: Male