C.R. BARD, INC. (COVINGTON) -1018233 PELVISOFT ACELLULAR COLLAGEN BIOMESH PELVISOFT® ACELLULAR COLLAGEN BIOMESH
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Catalog Number 481068 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Micturition Urgency (1871); Urinary Frequency (2275); Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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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 adverse events: ¿ precautions pelvisofttm biomesh is for single-patient use only and is to be implanted surgically.
If either the outer polyester/polyethylene pouch or the inner foil pouch has been perforated or torn in shipment or storage, then the enclosed pelvisofttm biomesh should not be used.
Pelvisofttm biomesh should be hydrated or moist when the package is opened.
Dehydrated or dry tissue should not be implanted.
" 2348, 2993, 2275, 1871 = "nl".
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Event Description
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The patient's attorney alleged a deficiency against the device.
Per additional information received, the patient has experienced frequent urination, pressure, urinary urgency, and frequency.
The patient required non-surgical interventions.
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Search Alerts/Recalls
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