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

Catalog Number	0112780
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2009 - patient was diagnosed with recurrent bilateral inguinal hernia thereby underwent open repair with implant of perfix plug (device 1 and 2).Per op notes, "a large direct inguinal hernia was identified on the right and same on the left.A perfix plug (device 1) was placed on the right and a perfix plug (device 2) was placed on the left and secured with suture." on (b)(6) 2016 - patient was diagnosed with recurrent bilateral inguinal hernia thereby underwent robotic assisted repair with implant of 3dmax mesh (device 3 and 4).Per op notes, "an incision was made at the umbilicus.Bilateral inguinal hernias were identified.The peritoneum above the hernia was opened.It was more of an eventration of mesh.The hernia sac was reduced and, on both sides, medium meshes (device 3 and 4) were placed and secured with suture.The peritoneum was re-closed with suture.".
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-sep-2007) 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 ; 8005566756
• MDR Report Key: 25590895
• Report Number: 1213643-2026-00783
• Device Sequence Number: 14823254
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622(17)121028(10)HURI1166
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 10/28/2012
• Device Catalogue Number: 0112780
• Device Lot Number: HURI1166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2007
• 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: 43 YR
• Patient Sex: Male