Model Number 802110 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2022 |
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 bd represents all 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 bd.
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Event Description
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It was reported that the patient was missing sterile gel.As per additional information on (b)(6) 2022, patient stated the tops kept popping off the leg bags.
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Manufacturer Narrative
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Upon further review, bd has determined that there was no allegation against product and previous mdr was reported in error.The device was not returned.
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Event Description
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It was reported that the patient was missing sterile gel.As per additional information on 23oct2022, patient stated the tops kept popping off the leg bags.
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Search Alerts/Recalls
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