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

Lot Number HUEW0355

Device Problem Contamination (1120)

Patient Problems Bacterial Infection (1735); Implant Pain (4561)

Event Date 04/02/2021

Event Type  Injury  

Event Description

We use a hernia mesh "perfix plug large" for our hernia cases.Dr (b)(6) has noted that since (b)(6) this year he has had 3 cases where patient's complained that the area hurt.With the first 2 cases he treated them with antibiotics and they got better.His last patient occurred in (b)(6).Dr (b)(6) removed the mesh and sent it for culture.The mesh came back (b)(6).All of these were open hernias and there was no way the mesh could have touched skin when it was inserted into the body.Therefore his conclusion is the mesh is contaminated.Dr (b)(6) stated he tried to call bard, but did not get any where.This was the 2nd issue, hernia removed and sent for culture, (b)(6).Is therapy still on-going? no.

• Brand Name: MARLEX MESH PERFIX PLUG
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.
• MDR Report Key: 11715849
• MDR Text Key: 247226752
• Report Number: MW5100946
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: HUEW0355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 101