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Model Number BG UNK |
Device Problems
Off-Label Use (1494); Chemical Problem (2893)
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Patient Problem
Cerebrospinal Fluid Leakage (1772)
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Event Type
Injury
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Event Description
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According to the bioglue post market survey form received via email on 01-mar-2021, a surgeon performed a reintervention due to a csf leak after using bioglue during the reconstruction of sellar [cellar] floor by trans-sphenoidal approach.Additional information provided by the director ra & bme of the (b)(4) bioglue distributor."this incident report by the surgeon is the reply on your survey for noncardiac case through website last week.For this survey, we have asked the surgeon and filled with his reply.And this is not recently occurred, and he has experienced over 10 years ago when he worked at sinchon severance hospital.This is just reply on your survey and not serious any more now, and also he has any information on this issue any more, too." no additional information forthcoming.
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Event Description
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According to the bioglue post market survey form received via email on 01-mar-2021, a surgeon performed a reintervention due to a csf leak after using bioglue during the reconstruction of sellar [cellar] floor by trans-sphenoidal approach.Additional information provided by the director ra & bme of the south korean bioglue distributor."this incident report by the surgeon is the reply on your survey for noncardiac case through website last week.For this survey, we have asked the surgeon and filled with his reply.And this is not recently occurred, and he has experienced over 10 years ago when he worked at sinchon severance hospital.This is just reply on your survey and not serious any more now, and also he has any information on this issue any more, too." no additional information forthcoming.
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Search Alerts/Recalls
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