Device Problems
Material Deformation (2976); Material Protrusion/Extrusion (2979); Mushroomed (2987)
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Patient Problems
Tissue Damage (2104); Hematuria (2558)
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Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.The device was not returned.
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Event Description
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It was reported that the catheter balloon had a cuff roll.As a result, the catheter allegedly had small protruding edges that caused urethral tearing with removal of the catheter, which resulted in hematuria.
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Manufacturer Narrative
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The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product catalog number is unknown, the silicone catheter product ifus are found to be adequate based on past reviews.
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Event Description
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It was reported that the catheter balloon had a cuff roll.As a result, the catheter allegedly had small protruding edges that caused urethral tearing with removal of the catheter, which resulted in hematuria.
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Search Alerts/Recalls
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