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Catalog Number 482150 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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November 2016 quarterly asr report (b)(4).The total number of events for product classification code pag is (b)(4).Qty 13-pelvilace biourethral support system 2 needle introducers, 1 disposable handle.4 tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.Qty 3- pelvilace to biourethral support system needle and implant halo needle 50cm.Qty 7- 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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November 2016 quarterly asr report.
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Manufacturer Narrative
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Exemption e2013025.Original reporting time frame august 1, 2016 through october 31, 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 august 1, 2016 through october 31, 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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