Catalog Number FOL0102 |
Device Problems
Use of Device Problem (1670); 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 was coming off within two weeks of application.
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Manufacturer Narrative
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The reported event was confirmed, as use-related per the event description and the ifu.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿the statlock® device should be assessed daily and changed when clinically indicated, at least every seven days.".
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Event Description
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It was reported that the statlock was coming off within two weeks of application.
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Search Alerts/Recalls
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