Device Problems
Failure To Adhere Or Bond (1031); Detachment of Device or Device Component (2907)
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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 statlock had weak adhesive and was not adhering to the patient's skin.It was reported that the patient does not clean his skin prior to placement of the statlock, and the statlock only lasts two days before falling off.
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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 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 statlock had weak adhesive and was not adhering to the patient's skin.It was reported that the patient does not clean his skin prior to placement of the statlock, and the statlock only lasts two days before falling off.
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Search Alerts/Recalls
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