Model Number 31140257 |
Device Problem
Split (2537)
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Patient Problem
No Information (3190)
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Event Date 09/13/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Submit date: 09/14/2016.An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove.The customer reports the light gloves are splitting.The customer is receiving 8-10 a day all from this same lot number that are splitting.The customer further reports no patient involvement and no medical intervention required.
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Manufacturer Narrative
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Additional information was provided by the customer.Lot#: originally reported as 6189100164 and should be 6169100164.
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Event Description
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The customer further reports that the lite glove was not too tight when placing on the handle.The split was found when placing on the handle during setup.This occurred when the patient was in the room.A new glove was placed once the tear was seen and the scrub tech changed gloves.A stryker handle was being used with the lite glove.The patient was not given any additional antibiotics as a result.
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Search Alerts/Recalls
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