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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 Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Incontinence (1928); Prolapse (2475)
Event Date 01/25/2012
Event Type  Injury  
Manufacturer Narrative
At this time no conclusions can be made. It is unknown to what extent the bard/davol bard flat mesh device may have caused or contributed to the events as alleged by the patient¿s attorney. Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Based on the limited information provided at this time, no conclusions can be made. Should additional information be provided a supplemental emdr will be submitted. Not returned.
 
Event Description
Per information provided by the patient's attorney, medical records & product id page: on (b)(6) 2008: the patient was diagnosed with uterine prolapse, stress incontinence and underwent a supracervical abd hysterectomy, retropubic urethropexy, cystotomy repair and sacrocolpopexy with implant of a bard/davol flat mesh. On (b)(6) 2012: the patient was diagnosed with recurrent stress urinary incontinence, symptomatic rectocele and underwent a posterior repair with "polypropylene mesh" (non davol), perineorrhaphy, sacrospinous ligament fixation and tvt placement (non bard/davol).
 
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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
8015652300
MDR Report Key9142543
MDR Text Key161953311
Report Number1213643-2019-09609
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2012
Device Catalogue Number0112660
Device Lot NumberHURI1112
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2007
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: 10/01/2019 Patient Sequence Number: 1
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