Model Number N/A |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
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Patient Problem
Laceration(s) (1946)
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Event Date 10/21/2016 |
Event Type
Injury
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Manufacturer Narrative
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The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This is one of two devices that may have been involved in the event.
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Event Description
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Patient alleged the size of the needle was larger than expected and she sustained a laceration on her arm as a result.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Review of the complaint history determined that no further action is required as no were trends identified.A definite root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer bimoet will continue to monitor for trends.
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Search Alerts/Recalls
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