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Catalog Number 1503831 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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A patient underwent an unspecified cardiac surgery in which ostene (3.5g) was used on the sternum.It was reported after use, blood started ¿oozing through again¿.The event occurred ¿after about 5 minutes, from the sternum¿.The physician reported the sternum ¿bleeds a lot due to its nature-it never completely ossifies as we age so produces a lot of bone marrow which has a tendency to bleed a lot¿.The product was applied after initially cutting through the sternum and at the end of the operation before ¿closing up¿.The physician expected the product to last 2 hours before it is dissolved.The patient was not hospitalized for the event.Treatment for the event was not reported.At the time of this report, the patient outcome was not reported.No additional information is available.
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Manufacturer Narrative
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Additional information, b5: upon follow up it was reported there was no patient injury (no further details).Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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