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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 0112680
Device Problem Defective Device (2588)
Patient Problem Prolapse (2475)
Event Date 04/21/2006
Event Type  Injury  
Manufacturer Narrative

At this time no conclusions can be made. The patient's attorney did allege the patient was diagnosed with symptomatic cystocele and underwent an anterior repair, however, no details have been provided regarding the nature of the injury. A review of the manufacturing records is not possible. No direct allegation was made against the bard flat mesh and it is unclear if the secondary intervention was a revision or involved as there is no indication of the visualization of the bard flat mesh. Should additional information be provided a supplemental emdr will be submitted. Not returned.

 
Event Description

Per legal claim and medical records: (b)(6) 1997: the patient was diagnosed with a vaginal vault prolapse and underwent a sacrocolpopexy with implant of a bard/davol bard flat mesh. (b)(6) 2006: the patient was diagnosed with symptomatic cystocele and underwent an anterior repair with implant of a non davol "pelvisoft" mesh.

 
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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
roxanne tidwell
100 crossings blvd.
warwick, RI 02886
8015652659
MDR Report Key8038757
MDR Text Key126149799
Report Number1213643-2018-03859
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 11/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0112680
Device LOT Number881600
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/05/2018 Patient Sequence Number: 1
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