• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH SURGICAL MESH

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH SURGICAL MESH Back to Search Results
Catalog Number 0112680
Device Problems Defective Device (2588); Material Protrusion/Extrusion (2979); Insufficient Information (3190)
Patient Problems Erosion (1750); Unspecified Infection (1930); Prolapse (2475); No Information (3190)
Event Type  Injury  
Event Description
As reported on 10/19/2016: 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: (b)(6) 1999 - the patient underwent a total vaginal hysterectomy, anterior and posterior colporrhaphy with bard flat mesh placement, pereyra with bard flat mesh and cystoscopy due to a history of pelvic prolapse and stress urinary incontinence. (b)(6) 2014 - patient underwent implant of a non bard/davol matristem graft. The attorney alleges the patient experienced an unspecified adverse outcome associated tot he use of the device. Addendum per medical records & pfs: legal claim (pfs) alleging pain, erosion, extrusion, infection, urinary and bowel problems, prolapse, bleeding, dyspareunia, vaginal scarring, and additional surgery.
 
Manufacturer Narrative
Addendum based on additional information provided by patients attorney which included medical records, patient fact sheet and general patient outcome allegations: at this time no conclusions can be made. It is unknown to what extent the bard/davol bard flat mesh device may have caused or contributed to the events. The information provided alleges as a result of the defective nature of them mesh the patient experienced pain, erosion, extrusion, infection, urinary and bowel problems, prolapse, bleeding, dyspareunia, vaginal scarring, and additional surgery. Regarding infection; the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. " a review of the manufacturing records was performed and found that the lot was manufactured to specification. 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.
 
Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event. The patient's attorney did not allege a specific device failure or patient injury and medical records were limited to the patient's implant op report and implant tracking log only. A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event. 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) 1999 the patient underwent a total vaginal hysterectomy, anterior and posterior colporrhaphy with bard flat mesh placement, pereyra with bard flat mesh and cystoscopy due to a history of pelvic prolapse and stress urinary incontinence. On (b)(6) 2014 patient underwent implant of a non bard/davol matristem graft. The attorney alleges the patient experienced an unspecified adverse outcome associated tot he use of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD FLAT MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key6042105
MDR Text Key291834690
Report Number1213643-2016-00482
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 12/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2004
Device Catalogue Number0112680
Device Lot Number43FJD225
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received11/20/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/19/2016 Patient Sequence Number: 1
-
-