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

Catalog Number 0112970

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, no conclusion can be made.As alleged, the patient experienced post-implant adverse outcomes including infection and, gangrene with subsequent mesh removal.Review of the manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in april, 2019.Infection is a known inherent risk of surgery.Regarding infection the instructions-for-use, supplied with the device, states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." this mdr represents the bard/davol perfix plug (device #2).An additional mdr was submitted to represent the bard/davol perfix plug (device #1).Not returned - mesh explanted.

Event Description

The following was reported via maude event report (mw5105877): "caller stated that he was implanted with a mesh (b)(6) 2019.One on the right side of the groin and another on the left side.Pt stated after implantation he started to experience pain in the groin area.Pt met with his doctor to discuss his symptoms, while he was at the doctor's office he fainted, he was later revived.Patient stated when he got home after meeting with his doctor he noticed that his body is inflamed and red.His son took him to the emergency room where he was admitted to the hospital.He was in the hospital for two weeks because he develop gangrene and his wound was infected.He was placed on antibiotics, he continued to received treatment until his wound is cleared from infection and healed.On (b)(6) 2021 the mesh was explanted." addendum per additional information: as reported, the patient was implanted with two bard/davol perfix plugs, underwent explant of both meshes and the patient continues to seek treatment.

• Brand Name: PERFIX PLUG
• Type of Device: 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: 13591065
• MDR Text Key: 286058227
• Report Number: 1213643-2022-00026
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: 0112970
• Device Lot Number: HUDQ0726
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male