Model Number 102096-67A |
Device Problem
Difficult to Remove (1528)
|
Patient Problem
Discomfort (2330)
|
Event Date 09/30/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
|
|
Event Description
|
On september 30th 2020, senseonics was made aware of an adverse event where the physician was unable to remove the sensor on the third removal attempt at different clinic and they were also unable to locate the sensor.
|
|
Manufacturer Narrative
|
Per case notes, customer asked to not be contacted again regarding removal of sensor.D2.Product code changed to qhj.H6.Investigation findings changed to 3221.H6.Investigation conclusions changed to 4311.
|
|
Search Alerts/Recalls
|