Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
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Event Description
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It was reported that the patient underwent an unknown procedure on unknown date and bone wax was used for control of bone bleeding and to seal air cells in the petrous bone to reduce chance of csf leak.The patient underwent re-operation to repair a csf leak.The surgeon opined the re-operation was required due to the sub-optimal adherence of the wax to the bone and its failure to stay in place allowing the csf leak to occur.At the time of re-operation the previously placed bone wax was dry, brittle, loosely attached to the bone.The patient is doing well currently.
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Manufacturer Narrative
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Corrected information: it was reported that this device is not malfunction reportable.Therefore, this medwatch report is not reportable.
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Search Alerts/Recalls
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