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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 0112640
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Erosion (1750); Incontinence (1928); Abnormal Vaginal Discharge (2123)
Event Date 06/01/2007
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned to manufacturer.

 
Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2005 - the patient underwent a bladder neck suspension with use of a bard flat mesh. On (b)(6) 2006 - (b)(6) 2007 - the patient was evaluated for symptoms of urinary incontinence, vaginal discharge and erosion of the vaginal mesh "sling. " on (b)(6) 2007 - the patient underwent explant of the bard flat mesh. Operative dictation notes a bladder laceration occurred during this procedure and noted to have "occurred at some point during retraction of the bladder. " on (b)(6) 2007 - the patient had post op visits where it was indicated the patient had some bladder spasm initially but overall without incontinence or urgency.

 
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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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key5818938
MDR Text Key50321371
Report Number1213643-2016-00342
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 ATTORNEY
Type of Report Initial
Report Date 06/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/30/2009
Device Catalogue Number0112640
Device LOT Number43EOD003
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received06/27/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/28/2004
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: 07/25/2016 Patient Sequence Number: 1
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