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

Catalog Number	0112960
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	01/12/2018
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-oct-2015) 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: on (b)(6) 2016: patient was diagnosed with left inguinal hernia, recurrent right inguinal hernia thereby underwent open repair with the implant of perfix plug (right - device 1, left - device 2).Per op notes, ¿weakness in the floor of the inguinal canal noted.The recurrent hernia was identified where the mesh was detached superiorly.The loose synthetic mesh was resected.A perfix plug (device 1) was placed into defect and onlay portion of mesh was placed over the old synthetic mesh using suture.On left side, hernia sac was dissected.The floor was repaired by placing a medium sized perfix plug (device 2) through the internal ring and keyhole portion of mesh was placed over the floor secured using sutures.¿ on (b)(6) 2018: patient was diagnosed with recurrent left inguinal hernia, two recurrent right inguinal hernia thereby underwent robotic assisted repair with the removal of mesh (device 1, 2) and implant of 3dmax meshes (device 3, 4).Per op notes, ¿patient had bilateral recurrent hernias.An old mesh plug (device 1) on right side.Significant amount of scar tissue and adhesion of peritoneal to right sided mesh.The recurrent hernia was reduced, and mesh (device 1) was excised.On left side, the recurrent hernia was noted.The floating piece of mesh plug (device 2) was excised which densely adhered to left sided vas deferens.A 3dmax meshes (device 3, 4) were placed into defect on both sides and sutured.¿.

• 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: 24266560
• Report Number: 1213643-2026-00086
• Device Sequence Number: 10021480
• Product Code: FTL
• UDI-Device Identifier: 00801741016660
• UDI-Public: (01)00801741016660(17)201028(10)HUZJ0756
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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: 10/28/2020
• Device Catalogue Number: 0112960
• Device Lot Number: HUZJ0756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2015
• 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 Age: 47 YR
• Patient Sex: Male