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

Catalog Number	0112770
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240)
Date of Event	01/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 9 years 10 months post implant of perfix plug, patient was diagnosed with hernia recurrence, adhesions, pain and scar tissue thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.This emdr represents the bard/davol perfix plug (device #2).An additional supplemental emdr was submitted to represent the bard/davol 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) 2007 - patient was diagnosed with reducible left direct and indirect inguinal hernia thereby underwent open repair with the implant of perfix plug (device #1, #2).Per operative notes, "scar tissue was noted in pubic tubercle, the spermatic cord and hernia sac were dissected down.The indirect hernia sac was excised.A small direct inguinal hernia was reduced.A perfix plug (device #1) was placed into direct hernia space secured.A perfix plug (device #2) was secured in the deep inguinal ring and sutured.The on-lay patch was secured to pubic tubercle.The ilioinguinal nerve was divided as it was running through scar tissue in line of dissection." (b)(6) 2017 - patient was diagnosed with recurrent right and left inguinal hernia thereby underwent laparoscopic repair with implant of synthetic meshes and explant of perfix plugs (device #1, #2).Per operative notes, "on right side, adhesions were noted to the peritoneum.A large hernia was noted and noted to be direct.The previous unknown plug was visible and adherent to multiple structures and were not unidentifiable these were taken down as possible.Bleeding was noted and controlled as the bladder was completely adhesed to peritoneum.On left side, upon entering was difficulty was noted due to scarring.Another mesh plug (device #1, #2) was noted.An indirect hernia was noted.The peritoneum was significantly attached to the plug mesh (device #1, #2) and was dissected out.The preperitoneal space was created a piece of a synthetic mesh was placed covering the hernia defect.Another piece of a synthetic mesh was placed on the right side covering the defect." attorney alleged that the patient had adhesions, pain, hernia recurrence, scar tissue, bladder repair, vasectomy and emotional injuries.

• Brand Name: PERFIX PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 21456266
• Report Number: 1213643-2025-090107
• Device Sequence Number: 12747025
• Product Code: FTL
• UDI-Device Identifier: 00801741016615
• UDI-Public: (01)00801741016615(17)110728(10)43GQD096
• 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: 2007
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

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: 07/28/2011
• Device Catalogue Number: 0112770
• Device Lot Number: 43GQD096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Male