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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
Model Number 0112680
Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)
Patient Problem Prolapse (2475)
Event Date 05/24/2007
Event Type  Injury  
Manufacturer Narrative

Based on the information provided, though the bard/davol flat mesh was noted to be partially detached on (b)(6) 2007, the patient appears to have symptoms mainly involving incontinence which has not been associated with the flat mesh device used in the patient's posterior repair. The cause of the partial mesh detachment can not be determined based on the currently available information. From 2010 - 2013 the patient was evaluated and the md confirmed no infection or mesh erosion to be present. With the current information available, no definitive conclusion can be made. If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.

 
Event Description

Based on a review of medical records and the patient's legal claim: this is a patient with a history of multiple comorbidities, as well as surgical procedures unrelated to vaginal prolapse repairs. On (b)(6) 2001 - the patient was diagnosed with vaginal vault prolapse with cystocele, stress urinary incontinence and underwent an anterior colporrhaphy with implant of a non-davol "pelvicol" graft. On (b)(6) 2004 - the patient was diagnosed with a vaginal vault prolapse and underwent an abd sacrocolpopexy with implant of a flat mesh. On (b)(6) 2007 - the patient was diagnosed with recurrent vaginal vault prolapse, stress urinary incontinence with relatively fixed urethra and underwent a repeat sacrocolpopexy with implant of a non-bard davol "gynecare" mesh, urethrolysis, tension-free vaginal tape followed by cystoscopy. Operative dictation notes: "bard graft for the sacral colpopexy was still attached to the patient's sacrum at the level of the promontory. However, there was complete detachment of this graft from the vagina, and the graft was retracted back out the upper portion of the lateral pelvic sidewall". On 2010-2013 - during this time the patient was evaluated in the md office for complaints of vaginal odor and discharge. The md was able to confirm no infection or mesh erosion to be present.

 
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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 Key8063677
MDR Text Key126926497
Report Number1213643-2018-03960
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,Followup
Report Date 12/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/28/2008
Device MODEL Number0112680
Device Catalogue Number0112680
Device LOT Number43LND021
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/08/2004
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: 11/13/2018 Patient Sequence Number: 1
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