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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 UNKAA030
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Pain (1994); Prolapse (2475)
Event Date 08/02/2001
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 adhesions and erosion. Adhesions are listed as a known adverse reaction in the instructions-for-use. While the medical records indicate a post operative diagnosis of erosion, there is no description of this in the operative details provided. Without a lot number a review of the manufacturing records could not be conducted. Additionally, no product was returned for evaluation. With the currently available information, no conclusion can be drawn. 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) 2001 - the patient was diagnosed with stress urinary incontinence, symptomatic enterocele and colonic bowel adhesions. The patient underwent a marshall-marchetti-krantz procedure, abdominal repair of enterocele, marlex mesh graft (bard / davol flat) on (b)(6) 2001 - the patient was diagnosed with severe pelvic pain at the site of the "marlex" mesh sacrocolpopexy and its attachment to the vagina and partial erosion. The patient underwent explant of the "marlex" and a vaginal vault suspension and enterocele repair with a modified mccall culdoplasty. At this time the patient had ureteral stents placed on (b)(6) 2006 - the patient had an md office visit with complaints of prolapse more pronounced with standing. There was concern to pursue surgery as the patient had severe chronic pain related issues and adhesions from previous surgeries. On (b)(6) 2007 - patient had an md office visit with continued complaints of pelvic pain and urgency symptoms, very similar to the pain experienced since 2001. Patient has symptoms consistent with pelvic pain syndrome. Md does not see an indication for surgery at this time. Patient treated with prescriptions and educational handouts.
 
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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 Key6171755
MDR Text Key62313948
Report Number1213643-2016-00572
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 12/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received11/21/2016
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: 12/13/2016 Patient Sequence Number: 1
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