Model Number 60-000-23-09 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cerebrospinal Fluid Leakage (1772)
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Event Date 11/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: mdr: 9610905-2018-00315; 9610905-2018-00316; 9610905-2018-00317; 9610905-2018-00318; 9610905-2018-00319; 9610905-2018-00320; 9610905-2018-00321.
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Event Description
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It was reported devices were removed due to patient condition.
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Manufacturer Narrative
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Device material number nor lot number was identified therefore complaint rate, review of device history records and risk file was not possible.The root cause for the failure cannot be determined since neither material nor lot number were provided and no product failure was described by the customer.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
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Search Alerts/Recalls
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