Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PELVILACE BIOURETHRAL SUPPORT SYSTEM
  • 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
 

C.R. BARD, INC. (COVINGTON) -1018233 PELVILACE BIOURETHRAL SUPPORT SYSTEM Back to Search Results
Catalog Number 482150
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Unspecified Infection (1930); Scarring (2061)
Event Type  Injury  
Manufacturer Narrative
The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the potential complications: complications associated with the proper implantation of the pelvilace biourethral support system may include, but are not limited to: postoperative hematoma.Temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder or bowel, which may occur during needle passage.(b)(4) 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.(b)(4) the total number of events for product classification code page is 12.Qty 4- pelvilace biourethral support system 2 needles introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.Qty 2- pelvilace to biourethral support system.Qty 6- pelvilace biourethral support system needle and implant hook needle 50cm.
 
Event Description
The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced pelvic discomfort, hypotension, recurrence, extrusion, pain, erosion, infection, unspecified urinary problems, dyspareunia, blood loss, mixed and stress urinary incontinence, bladder neck defect, blood loss, nocturia, dribbling, leaking urine with coughing/laughing/sneezing/bearing down/walking/standing/physical exertion, first degree cystocele (prolapse), vaginal scarring (scarring), blood tinged urine (hematuria), vaginal spotting, drainage, vaginal wall wound (vaginal mucosa damage), vaginal wall defect, feels wire inside vaginal wall (foreign body sensation), sleepiness and required additional surgical and non-surgical interventions.
 
Manufacturer Narrative
(b)(4).Original reporting time frame september 1, 2015 to october 31, 2015.
 
Manufacturer Narrative
(b)(4).Original reporting time frame (b)(4) 2015.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.
 
Manufacturer Narrative
(b)(4).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.
 
Manufacturer Narrative
(b)(4).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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PELVILACE BIOURETHRAL SUPPORT SYSTEM
Type of Device
PELVILACE BIOURETHRAL SUPPORT SYSTEM
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
unit 1
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
unit 1
covington GA 30014
Manufacturer Contact
angela robinson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key5254130
MDR Text Key32288325
Report Number1018233-2015-00508
Device Sequence Number1
Product Code PAG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2008
Device Catalogue Number482150
Device Lot NumberCVQI0001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Device Age4 MO
Event Location Hospital
Date Manufacturer Received09/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age43 YR
Patient Weight68
-
-