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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH SURGICAL MESH Back to Search Results
Catalog Number 0112660
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative

As reported, the patient was implanted with a bard flat mesh and is alleging chronic infection about 6 months post implant. The information provided is limited to the maude event report. Contact information was not provided, therefore, we are unable to request additional information. Based on the limited information provided, it is unclear as to what may have caused the reported event and no conclusion can be made at this time. Review of manufacturing records indicate product was manufactured to specification. To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in may, 2017. In regards to the infection. The instructions-for-use (ifu) 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. " should additional information be provided, a supplemental emdr will be submitted. Not returned - remains implanted.

 
Event Description

The following was reported via maude event report (mw5096057): patient alleges following adverse outcomes against bard mesh "chronic mesh infection, chronic open wound from 10"x14" bard mesh. Fda safety report id#: (b)(4). ".

 
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Brand NameBARD FLAT MESH
Type of DeviceSURGICAL 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 Key10524985
MDR Text Key206772781
Report Number1213643-2020-08241
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 09/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0112660
Device LOT NumberHUBQ2586
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/09/2017
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: 09/11/2020 Patient Sequence Number: 1
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