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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 0112670
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Fistula (1862); Prolapse (2475)
Event Date 09/12/2016
Event Type  Injury  
Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol bard flat mesh device may have caused or contributed to the reported events. Adhesion is a known inherent risk of surgery and is listed in the instructions-for-use as a possible complication. Fistula formation is a known inherent risk of surgery and is listed in the instructions-for-use as a possible adverse reaction. 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) 2000: the patient was diagnosed with vaginal prolapse, urinary incontinence and underwent an abd sacrocolpopexy with implant of a bard/davol flat mesh. On (b)(6) 2001: the patient was diagnosed with vaginal prolapse and underwent a revision procedure, anterior colporrhaphy, anterior repair, laparotomy and lysis of adhesions. On (b)(6) 2016: the patient was diagnosed with a colovaginal fistula and underwent an exploratory laparotomy with takedown and repair of colovaginal fistula, sigmoid colon, small bowel resection, removal of the bard/davol flat mesh, repair of incarcerated hernia and an incidental appendectomy.

 
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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 Key8741441
MDR Text Key149421425
Report Number1213643-2019-05537
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 06/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0112670
Device LOT Number43KJD293
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
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: 06/27/2019 Patient Sequence Number: 1
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