Model Number 3034-00 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Laceration(s) (1946)
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Event Date 08/29/2017 |
Event Type
Injury
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Manufacturer Narrative
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No evaluation possible as the device was not returned.Because the customer could not allocate the exact product to the event, there are in total three mdr's generated for three possible products, although there was only one event.
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Event Description
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Customer service was contacted on 08/30/2017 from distributor.Distributor stated that she was contacted from customer on 08/30/2017: customer has a clamp that needs repair.It happens during patient incident.Customer service called customer on (b)(6) 2017: event with patient involvement on (b)(6) 2017.Unknown if patient was injured.Customer stated he has 3 skull clamps but do not know which one the incident happened with.Patient being flipped prone from supine and that¿s when the skull clamp slipped".
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Event Description
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User stated: tension spring feels loose.Description of injury: patient had a laceration on side of head.Procedure performed: laminectomy.Patient positioning: prone surgery completed: yes.Date of incident: (b)(6) 2017.
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Search Alerts/Recalls
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