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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 Problem Defective Device (2588)
Patient Problems Neuropathy (1983); Pain (1994); Disability (2371)
Event Date 03/28/2014
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. Medical records provided to date do not include the implant or explant operative report for the bard mesh, therefore, no evaluation can be done in regards to the allegations of hole in a bladder and water in the lungs. With the current information available, no definitive conclusion can be made. 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 limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2011 - patient underwent implant of a bard flat mesh to repair a bladder prolapse. On (b)(6) 2011 - the patient presented to the er with complaints of bilateral leg pain. On (b)(6) 2014 - the patient underwent removal of the bard flat mesh, it was reported there was a little of the mesh that could not be removed. It was further reported that there was a hole in the patient's bladder and water in her lungs during the explant procedure which prevented full removal of the mesh. On (b)(6) 2014 - the patient was diagnosed with vaginal prolapse and underwent vaginal reconstruction, four corner bladder neck suspension, vaginal vault suspension and anterior/posterior colporrhaphy. The patient alleges having pain to the legs and lower back, inability to walk, with damage to the nerves in the legs (neuropathy), ligaments and veins damaged. Patient reports being disabled because of the mesh.
 
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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 Key7302436
MDR Text Key101146067
Report Number1213643-2018-00404
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 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2013
Device Catalogue Number0112660
Device Lot NumberHUSD1723
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 Received02/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2008
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: 02/28/2018 Patient Sequence Number: 1
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