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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH SURGICAL MESH Back to Search Results
Catalog Number 0112680
Device Problems Material Deformation (2976); Patient Device Interaction Problem (4001)
Patient Problem Erosion (1750)
Event Date 09/11/2020
Event Type  Injury  
Manufacturer Narrative

As reported, it is alleged that the bard marlex mesh (bard flat mesh), implanted during a radical hysterectomy procedure was eroding into organs. Based on the limited information provided, it is unclear as to the degree to which the bard marlex mesh (bard flat mesh) may have caused or contributed to the patient¿s postoperative course. A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification. To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in january, 2013. Should additional information be provided, a supplemental mdr will be submitted. Remains implanted.

 
Event Description

The following was reported via maude event report (mw5097420): "ob/gyn found mangled ball of mesh that's eroding into organs. Surgery with a urogynecologist is required and currently being scheduled. Bard marlex that was used during radical hysterectomy. Fda safety report id# (b)(4). " addendum per additional information: as reported, the patient was seen by a doctor who told that the mesh was eroding and needs to consult with another doctor to discuss the treatment options. No further information was provided.

 
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Brand NameBARD FLAT MESH
Type of DeviceSURGICAL 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 Key10884782
MDR Text Key217666502
Report Number1213643-2020-20056
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 11/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2018
Device Catalogue Number0112680
Device LOT NumberHUWL1295
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/21/2013
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: 11/23/2020 Patient Sequence Number: 1
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