Catalog Number NL-12853-MUMC |
Device Problems
Difficult or Delayed Positioning (1157); Difficult or Delayed Activation (2577)
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Patient Problems
Abrasion (1689); Injury (2348)
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Event Date 06/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).No sample will be returned for evaluation.
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Event Description
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It was reported that the user met with difficulty when opening the scalpel.Force was then used resulting in the user cutting his hand requiring stitches.There was no reported delay, death, or complications to the patient as a result of this occurrence.
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Manufacturer Narrative
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(b)(4).No sample will be returned for evaluation.Additional information: this product is not sold in the us.The 510k number provided is for a similar product that is sold in the us.
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Event Description
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It was reported that the user met with difficulty when opening the scalpel.Force was then used resulting in the user cutting his hand requiring stitches.There was no reported delay, death, or complications to the patient as a result of this occurrence.
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Search Alerts/Recalls
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