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 Code	Hernia (2240)
Date of Event	05/31/2016
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-may-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 3dmax 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.
Event or Problem Description
Per information provided: on (b)(6) 2014 - patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax mesh (device 1).Per op notes, "a 3dmax mesh (device 1) was placed in the preperitoneal space on the right side covering both the direct and indirect space as well as the femoral space." on (b)(6) 2014 - patient was diagnosed with left inguinal hernia thereby underwent repair with the implant of perfix plug (device 2).(notes: no op notes were provided).On (b)(6) 2016 - patient was diagnosed with recurrent inguinal hernia thereby underwent laparoscopic bilateral repair with the removal of mesh (device 1) and implant of ventrio mesh (device 3) and composix kugel mesh (device 4).Per op notes, "patient had recurrent hernias on both the left and right side.On the patient's left side, there is a plug (device 2) visible in the indirect space.On the right side, a flat mesh (device 1) is present covering the entire groin.The groin was reinforced on both the left and right side using a ventrio mesh (device 3) towards the peritoneal cavity.The patient was seen to have an thin bladder wall which had torn where it was adherent to the prior hernia mesh.During this portion of the procedure, the hernia mesh (device 1) was removed on the patient's right side.A composix kugel mesh (device 4) was placed to the abdominal wall using prolene sutures.".

• 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: 23941271
• Report Number: 1213643-2025-01294
• Device Sequence Number: 21522019
• Product Code: FTL
• UDI-Device Identifier: 00801741016592
• UDI-Public: (01)00801741016592(17)190528(10)HUYE0653
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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: 05/28/2019
• Device Catalogue Number: 0112750
• Device Lot Number: HUYE0653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2014
• 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: 26 YR
• Patient Sex: Male