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

Catalog Number	0112780
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Seroma (2069); Hernia (2240)
Date of Event	08/29/2017
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.This emdr was submitted to represent the bard/davol perfix plug (device #3).Additional supplemental emdr represents the bard/davol perfix plug (device #1 & #2) and emdr was submitted to represent the bard/davol 3d max mesh (device #4).Note, the manufacturing date (15-sep-2016) is considered to be a best estimate.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) 2016 - patient was diagnosed with right direct inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1).Per operative notes, "a large direct defect was noted and inverted.A perfix plug (device #1) was placed in the hernia sac and sutured.The onlay patch was placed on the floor of the canal.Second piece of mesh (device #4) was noted." (b)(6) 2016 - patient was diagnosed with recurrent direct right inguinal hernia thereby underwent open repair with the implant of perfix plugs (device #2, #3).Per operative notes, "seroma cavity was noted and resected.The defect was medial, the previous patch (device #1) had pulled away from the superior aspect.Two perfix plugs (device #2, #3) were sutured inferiorly to the mesh.The patch was placed to the floor of the canal." (b)(6) 2016 - patient underwent aspiration of seroma.(b)(6) 2017 - patient was diagnosed with recurrent right inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax mesh (device #4).Per operative notes, "large complex defect in right groin with large hernia sac was noted.Small hernia was noted in indirect space as well.Scar tissues were removed.Previous mesh plug was noted within indirect space, densely incorporated.A 3dmax mesh (device #4) was placed and tacked.On left inguinal canal, eventration in indirect space was noted and repaired." (b)(6) 2018 - patient was diagnosed with right inguinodynia and foreign body granuloma of soft tissue thereby underwent right groin exploration and removal of mesh (device #1, #2 #3 and #4).Per operative notes, "the meshoma was seen.The mesh plug had extruded completely from the inguinal canal.The piece of mesh was removed.".

• 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: 22286340
• Report Number: 1213643-2025-00497
• Device Sequence Number: 15672491
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622(17)210828(10)HUAW0913
• 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: 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): 06/10/2025

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: 08/28/2021
• Device Catalogue Number: 0112780
• Device Lot Number: HUAW0913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2016
• 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: 72 YR
• Patient Sex: Male