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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 Adhesion(s) (1695); Fistula (1862); Pain (1994)
Event Date 10/17/1996
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. The medical records indicate the patient experienced prolapse, adhesions, fistula, bleeding and pain. Adhesions and fistula are listed as known possible adverse reactions in the instructions-for-use. Due to the age of the device a review of the manufacturing records was not readily performed at this time. No conclusions can be made at this time. 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.
 
Event Description
The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 1994 - the patient was diagnosed with uterine prolapse, cystocele and rectocele. The patient underwent a total abdominal hysterectomy and suspension of vaginal vault with davol flat mesh. On (b)(6) 1996 - the patient complained of bloody vaginal drainage and vaginal pain. The patient was diagnosed with a vaginal fistula and rectocele, the patient underwent resection of the davol flat mesh, extensive lysis of adhesions, abdominorectus fascia sacrocolpopexy, rectocele repair and abdominoplasty. Based off the operative report provided, it appears the flat mesh was completely removed during this procedure.
 
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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)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
Manufacturer Contact
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key6194438
MDR Text Key62972021
Report Number1213643-2016-00581
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 Attorney
Type of Report Initial
Report Date 12/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0112660
Device Lot Number704600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received11/30/2016
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: 12/21/2016 Patient Sequence Number: 1
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