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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PELVILACE BIOURETHRAL SUPPORT SYSTEM
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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 Problem Injury (2348)
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 precautions: the pelvilace¿ biourethral support system is for single-patient use only and is to be implanted surgically.Do not use the pelvilace¿ biourethral support system if the integrity of the packaging appears compromised the pelvilace¿ biourethral support system pelvicol® implant should be hydrated or moist when the package is opened.Dehydrated or dry tissue should not be implanted.Postoperative retropubic bleeding may occur in some patients and must be controlled prior to patient release.The pelvilace¿ biourethral support system procedure requires diligent attention to anatomical structure and care to avoid puncture of large vessels, nerves, bladder, and bowel, during needle passage.Proper placement of the pelvilace¿ biourethral support system at mid-urethra requires that the tissue lie flat with minimal or no tension under the urethra.The pelvilace¿ biourethral support system is intended as a single-use, disposable device.Do not resterilize any portion of the pelvilace¿ biourethral support system.Patients should be advised that pregnancy following an pelvilace¿ biourethral support system procedure may negatively affect the success of the previous procedure and incontinence may reoccur.The safety and effectiveness of pelvilace¿ biourethral support system has not been established for the treatment of stress urinary incontinence in males and children under the age of 18.(b)(4).The total number of events for product classification code pag is (b)(4).Qty (b)(4) pelvilace biourethral support system 2 needles introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling; qty (b)(4) pelvilace to biourethral support system; qty (b)(4) pelvilace to biourethral support system needle and implant halo needle 50cm; qty (b)(4) pelvilace biourethral support system needle and implant hook needle 50cm.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.
 
Event Description
The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.
 
Manufacturer Narrative
(b)(4).Original reporting time frame august 1, 2015 to october 31, 2015.
 
Manufacturer Narrative
(b)(4).Original reporting time frame august 1, 2015 to october 31, 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).Original reporting time frame august 1, 2015 to october 31, 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
Exemption (b)(4).
 
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.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Exemption e2013025.Original reporting time frame august 1, 2015 through october 31, 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.
 
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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 Key5254206
MDR Text Key32297927
Report Number1018233-2015-00519
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 11/15/2018
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 Date08/06/2011
Device Catalogue Number482150
Device Lot NumberCVTA0007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Device Age5 MO
Event Location Hospital
Date Manufacturer Received07/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/21/2009
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 Age35 YR
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