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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC.BARD PELVILACE BIOURETHRAL SUPPORT SYSTEM

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C.R. BARD, INC. BARD PELVILACE BIOURETHRAL SUPPORT SYSTEM   Back to Search Results
Catalog Number 482150
Device Problems Reaction; Implant extrusion
Event Type  Injury   Patient Outcome  Required Intervention
Manufacturer Narrative

No sample was returned for evaluation. The lot is unknown; therefore, no review of the device history record could be performed. The product is manufactured using a controlled and validated manufacturing process. The product is terminally sterilized by irradiation and has undergone sterilization validation and dose audit studies. Routine product bioburden monitoring is performed to help safeguard sterility assurance. Product and packaging inspection stages have been implemented in conjunction with a validated process and documented systems to help safeguard and assure product quality. An analysis of the labeling confirms the ifu notes that the implant procedure and instrumentation associated with the surgical placement of the product can carry a inherent risk of infection, as do similar urological procedures. Procedural complications can include transitory irritation at the operative wound site, which may elicit a foreign body response that leads to wound dehiscence, inflammation, infection, or erosion of the implant. A review of complaint history did not show this type of problem reported before for this product code. Baseline report previously filed.

 
Event Description

It was reported that 2-3 months following, a second urethral sling procedure in 2006, the patient vaginally extruded pieces of the urethral sling material over the course of 1-2 weeks. The patient was diagnosed during a physical exam. Vinyl sutures with a continuous stitch were used to close the vaginal incision. The vaginal mucosa was trimmed prior to closure. The vaginal mucosa incision was closed loosely. The patient was given keflex post-op. The patient was noted as incontinent as of three months later. No further complications have been reported.

 
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Brand NameBARD PELVILACE BIOURETHRAL SUPPORT SYSTEM
Type of DeviceBIOURETHRAL SUPPORT SYSTEM
Baseline Brand NameBARD PELVILACE BIOURETHRAL
Baseline Generic NameBIOURETHRAL SUPPORT SYSTEM
Baseline Catalogue Number482150
Baseline Device FamilyPELVILACE BIOURETHRAL SUPPORT SYSTEM
Baseline Device 510(K) NumberK031295
Baseline Shelf Life Information Yes
Is Baseline PMA Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed05/20/2003
Manufacturer (Section F)
C.R. BARD, INC.
8195 industrial blvd.
covington GA 30014
Manufacturer (Section D)
C.R. BARD, INC.
8195 industrial blvd.
covington GA 30014
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
astley lane industrial estate
unit 1
swillington,leeds
UNITED KINGDOM LS26 8XT
Manufacturer Contact
vivian stephens, manager
8195 industrial blvd.
covington , GA 30014
(770) 784 -6902
Device Event Key819763
MDR Report Key832434
Event Key795410
Report Number1018233-2007-00017
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/26/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number482150
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Other
Date Manufacturer Received02/27/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/26/2007 Patient Sequence Number: 1
#TreatmentTreatment Date
UNK
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