Catalog Number CS-A4-EMS-XX |
Device Problems
Overheating of Device (1437); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Overheating is a known failure mode in the cooltone risk documents.A supplemental report will be submitted if and when additional information is obtained.
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Event Description
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Allergan aesthetics received a report of overheating of cooltone device on (b)(6) 2021.
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Manufacturer Narrative
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H11: corrected data: there is no serious injury associated with this event.Allergan has notified the manufacturer zimmer medizinsysteme of the event.
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Event Description
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Allergan aesthetics received a report of overheating of cooltone device on (b)(6) 2021.
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Search Alerts/Recalls
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