Device Problems
Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Component Falling (1105)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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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 adhesive on the statlock was weak, which caused the statlock to fall off the patient's leg after 2 days of use.
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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.The product family for this statlock sl foley is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the statlock sl foley 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 adhesive on the statlock was weak, which caused the statlock to fall off the patient's leg after 2 days of use.
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Search Alerts/Recalls
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