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Model Number BG UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Discharge (2225)
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Event Date 10/02/2019 |
Event Type
Injury
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Manufacturer Narrative
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This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
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Event Description
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According to the initial report, "yesterday, i had a meeting with one of the neurosurgeon in the mena region, and he stopped using bioglue, the reason is that he faced some post-operative complications (neurological discharge in 3-4 cases).".
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Manufacturer Narrative
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The manufacturing records could not be reviewed as a lot number nor a date of surgery was provided.Neither the quanitity of bioglue applied nor the surgical application (i.E., as an adjunct to the sututre, in conjunction with a dural patch material, etc.) are known.Additionally, the surgeon does not describe the nature of the discharge.A foreign body type inflammatory response to bioglue cannot be excluded.In the absence of additional information, it is not possible to definitively determine the cause of the events observed in the patient.There is no statement restricting the use of bioglue for general neurological procedures in canada.Per the ifu (instructions for use), bioglue is contraindicated for use in the cerebrovascular repairs and any intra-luminal areas.There is also the following statement in the ifu, ¿due to clinical reports of ineffective sealing when bioglue is used in the translabyrinthine approach for acoustic neuroma repairs, its use with this surgical approach is not recommended¿.There is insufficient information available to determine a root cause for the reported events.Foreign body inflammatory reactions to bioglue are known to occur and is listed as a potential complication in the ifu.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
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Event Description
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According to the initial report, "yesterday, i had a meeting with one of the neurosurgeon in the mena region, and he stopped using bioglue, the reason is that he faced some post-operative complications (neurological discharge in 3-4 cases),".
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Search Alerts/Recalls
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