Catalog Number C01A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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Two quantity of product (c01a) with lot number (el29209) were used, but it is unknown which product caused the event.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.
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Event Description
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It was reported that the patient was hospitalized on (b)(6) 2011 and was discharged on (b)(6) 2011 for balloon kyphoplasty at l2, due to compression fracture due to osteoporosis.The physician had judged bkp as effective in this patient.The product came in contact with the patient.Health damage to the patient was reported.Pain worsened.Nrs score worsened to 5.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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