Model Number 9438-06 |
Device Problem
Unintended Electrical Shock (4018)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/13/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the sensor was producing shock.The sensor was inserted into the abdomen on (b)(6) 2021.No product or data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
Subsequent to the initial mdr, a additional information was provided.
|
|
Event Description
|
Subsequent to the initial mdr, additional information was provided.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Search Alerts/Recalls
|