Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Shock (2072)
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Event Type
Injury
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Event Description
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It was reported by that the physician of the patient felt a "shock" while using her bone stimulator.The patient then saw a blister on the lateral side of her ankle.The patient stated that it happened once.There was a little blister, and the patient put a band-aid on it.The doctor prescribed antibiotics, doxycyclune hyclate 100mg, twice a day for 10 days.The patient was told to put antibiotic ointment on the area.The patient felt an electrical shock on the bone.The pain level was a 7 on the surface of the skin.The blister is healing right now.No additional patient consequences were reported.The coil was later returned for evaluation.
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Manufacturer Narrative
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The device was returned to zimmer biomet for investigation.No physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint.The device operated/functioned as intended.The device history record (dhr) was reviewed and no discrepancies were found.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in october 2021.Medical product: bone healing system.Physical therapy date: unknown.Date received by manufacturer.Device evaluated by manufacturer: yes.(b)(4).Narratives/data.
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Manufacturer Narrative
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The device was returned to zimmer biomet for investigation.No physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint.The device operated/functioned as intended.The device history record (dhr) was reviewed and no discrepancies were found.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: bone healing system.Physical therapy date: unknown.Date received by manufacturer.Device evaluated by manufacturer: yes.(b)(4).
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Event Description
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It was reported by that the physician of the patient felt a "shock" while using her bone stimulator.The patient then saw a blister on the lateral side of her ankle.The patient stated that it happened once.There was a little blister, and the patient put a band-aid on it.The doctor prescribed antibiotics, doxycycline hyclate 100mg, twice a day for 10 days.The patient was told to put antibiotic ointment on the area.The patient felt an electrical shock on the bone.The pain level was a 7 on the surface of the skin.The blister is healing right now.No additional patient consequences were reported.The coil was later returned for evaluation.
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Search Alerts/Recalls
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