C.R. BARD, INC. (COVINGTON) -1018233 PELVILACE TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
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Catalog Number 482151 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Urinary Tract Infection (2120); Dysuria (2684)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Qty 3-pelvilace biourethral support system 2 needle introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine accellular collagen matrix sling; qty 12- pelvilace to 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.Sample not returned.
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Event Description
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(b)(4).
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Manufacturer Narrative
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Exemption e2013025.Original reporting time frame may 1, 2016 through june 30, 2016.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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Manufacturer Narrative
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Exemption e2013025.Original reporting time frame may 1, 2016 through june 30, 2016.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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Search Alerts/Recalls
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