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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 Folded (2630); Extrusion (2934); Material Deformation (2976)
Patient Problems Adhesion(s) (1695); Erosion (1750); Seroma (2069)
Event Date 11/15/2016
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 provided indicate the patient experienced mesh extrusion, folded mesh, adhesions, erosion and a seroma post explant procedure performed in (b)(6) 2016. Extrusion, adhesions and seroma are all listed as known possible adverse reaction in the instructions-for-use. A manufacturing review was performed which found no anomalies during the manufacturing process of the device. Based on the information provided, it can not be determined whether the bard mesh may have caused or contributed to the problems experienced post implant due to the patient's history of previous abdominal/pelvic procedures and the additional non-bard davol mesh implanted. 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: (b)(6) 2014 - the patient was diagnosed with vaginal vault prolapse, grade ii lateral recurrent cystocele and stress urinary incontinence. The patient underwent a robotic sacrocolpopexy with implant of a bard flat mesh, bilateral culdoplasty and implant of a non-bard davol retropubic midurethral sling followed by cystoscopy. Of note exam of the interior of the abdomen revealed adhesions from her prior surgery. On (b)(6) 2016 - the patient was diagnosed with extrusion of vaginal mesh and underwent a partial excision of the "sacrocolpopexy mesh" (bard flat mesh). Per the operative details "the mesh was noted to contracted and it had a fold. " the mesh was then grasped and excised until the exposed tissue was no longer visible. On (b)(6) 2016 - the patient was diagnosed with exposure of "sacrocolpopexy" vaginal mesh and underwent an excision of "approx. 2cm segment of the exposed vaginal mesh from the left apex. " on (b)(6) 2016 - the patient was diagnosed with exposure of the vaginal mesh from abdominal sacrocolpopexy into vagina. The patient underwent open excision of mesh, open uterosacral ligament suspension and cystoscopy. Per the operative details "the vaginal portion of the mesh appeared to have eroded into the vagina. The mesh was excised, with removal of the entire vaginal component of mesh, but leaving some of the sacral limb in place. " furthermore it was noted that the mesh had to be separated from the mesentery of the sigmoid colon, and this was done without injury to the sigmoid colon. On (b)(6) 2016 - the patient underwent a ct guided seroma drainage with removal of "serous fluid. ".
 
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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 Key6560113
MDR Text Key74936480
Report Number1213643-2017-00299
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 05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2018
Device Catalogue Number0112670
Device Lot NumberHUXH0140
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2013
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: 05/11/2017 Patient Sequence Number: 1
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