Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Unspecified Infection (1930); Irritation (1941)
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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 patient allegedly developed irritation and a bladder infection during use of the catheter.The patient was hospitalized.
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Manufacturer Narrative
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The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the silicone catheter 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 patient allegedly developed irritation and a bladder infection during use of the catheter.The patient was hospitalized.
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Search Alerts/Recalls
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