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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MARLEX MESH PERFIX PLUG MESH, SURGICAL, POLYMERIC Back to Search Results
Lot Number HUEU4176
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 01/22/2021
Event Type  Injury  
Event Description

We use a hernia mesh "perfix plug large" for our hernia cases. (b)(6) has noted that since january 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 april. (b)(6) removed the mesh and sent it for culture. The mesh came back (b)(6) positive. 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. (b)(6) stated he tried to call bard, but did not get any where. This was the first case , antibiotics, no culture. Is therapy still on-going? no.

 
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Brand NameMARLEX MESH PERFIX PLUG
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
MDR Report Key11715841
MDR Text Key247227161
Report NumberMW5100945
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)Y
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received04/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device LOT NumberHUEU4176
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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