Catalog Number W31C |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The photo upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information 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 a patient underwent an unknown procedure on unknown date in 2019 and bone wax was used.The bone was hard to form, not soft and blood not getting stopped from bone.Very difficult case.The procedure was delayed 15 minutes.The applied product was removed as much as possible.There were no adverse patient consequences reported.
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Manufacturer Narrative
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(b)(4).Additional investigation summary: upon visual inspection of the pictures, an opened sample of product code w31c could be observed.However, no conclusion could be reach as the sample was not returned for analysis.The manufacturing record evaluation review could not be conducted, because the batch number of the complaint is unknown.
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Search Alerts/Recalls
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