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

Catalog Number 0112950

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Dysuria (2684)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including pain, trouble during urinating and infection; however, no details have been provided. A review of the manufacturing records was performed and found that the lot was manufactured to specification. In regards to the infection, the warnings section of the instructions for use (ifu) 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. " should additional information be provided, a supplemental emdr will be submitted. Not returned.

Event Description

Attorney alleges that the patient was implanted with a bard/davol perfix plug on (b)(6)2019. Attorney alleges that the patient sustained serious personal injuries and damages as a result of the defective device. Attorney alleges that from the date of implant of hernia mesh, the patient has experienced extreme pain, trouble urinating, infections and other ongoing problems as a direct result of the hernia mesh. Attorney also alleges that the device was defective.

• Brand Name: PERFIX PLUG
• Type of Device: 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: 12509830
• MDR Text Key: 272582892
• Report Number: 1213643-2021-07613
• Device Sequence Number: 1
• Product Code: FTL
• 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

• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0112950
• Device Lot Number: HUBZ1781
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/21/2021 Patient Sequence Number: 1