Catalog Number 270449 |
Device Problem
Defective Component (2292)
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Patient Problem
Laceration(s) (1946)
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Event Date 06/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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Pr 1798600 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: 1946, patient problem code: 2292.
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Event Description
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It was reported that a glass shard went though the applicator and cut the user on the hand causing bleeding.
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Event Description
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It was reported that a glass shard went though the applicator and cut the user on the hand causing bleeding.
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Manufacturer Narrative
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No samples or photos available for analysis.A visual inspection of retained samples were performed.There were no visual signs of cracked tubes, broken ampoules and/or shards of glass.However, historical trend has shown that this failure mode may occur due to the design when multiple activation occurs.Instructions for use specify that to activate applicator it needs to be squeezed gently ¿only once¿.If the applicator was pinched several times this could be the probable cause for the failure mode.No further actions are required at this time.This failure mode will continue to be tracked and trended.H3 other text : see narrative below.
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Search Alerts/Recalls
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