Catalog Number 5407120482 |
Device Problem
Overheating of Device (1437)
|
Patient Problems
Superficial (First Degree) Burn (2685); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/31/2024 |
Event Type
malfunction
|
Event Description
|
This report summarizes (b)(4) malfunction events in which the device reportedly overheated.- (b)(4) events had no patient involvement; no patient impact.- (b)(4) events had patient involvement; no patient impact.- (b)(4) event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
|
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: (b)(4) events were reported for this quarter.Product return status: (b)(4) devices were received.(b)(4) devices were evaluated based on historical data analysis.Additional information: (b)(4) devices were not labeled for single-use.(b)(4) devices were not reprocessed or reused.
|
|
Search Alerts/Recalls
|