Model Number 3C98-3 |
Device Problem
Unintended System Motion (1430)
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Patient Problem
Damage to Ligament(s) (1952)
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Event Date 11/04/2022 |
Event Type
Injury
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Event Description
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While walking the knee gave out; level walking; patient fell.Tore rotator cuff - necessitates med.Treatment.Noise - hissing / gurgling.Battery-/charging issue - battery charge does not last long.
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Manufacturer Narrative
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Device is currently not available for evaluation; supplemental report will be submitted after evaluation of all device components is completed.
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Event Description
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While walking the knee gave out; level walking; patient fell and tore rotator cuff - necessitates med.Treatment.Noise - hissing / gurgling.Battery-/charging issue - battery charge does not last long.Further information received on 12/07/2022:medical treatment: put in sling (outpatient treatment).
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Manufacturer Narrative
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Further information received on 12/07/2022: medical treatment: put in sling (outpatient treatment) which resulted in a lower extent of damage and correction of health effect code (h6).
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Event Description
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While walking the knee gave out; level walking; patient fell.Tore rotator cuff - necessitates med.Treatment.Noise - hissing / gurgling.Battery-/charging issue - battery charge does not last long.Further information received on 12/07/2022: medical treatment: put in sling (outpatient treatment).
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Search Alerts/Recalls
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