FDA Adverse Event
Injury
Summary report: N
EVERSENSE SENSOR
MDR report key: 12558709
·
Received September 30, 2021
Report
- Report Number
- 3009862700-2021-00120
- Event Type
- Injury
- Date Received
- September 30, 2021
- Date of Event
- September 1, 2021
- Report Date
- September 1, 2021
- Manufacturer
- SENSEONICS INC.
- Product Code
- QHJ
- UDI-DI
- 00817491022349
- PMA / PMN Number
- P160048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
PER CASE COMMENTS. SENSOR WAS SUCCESSFULLY REMOVED, DURING A FOLLOW UP REMOVAL ATTEMPT ON (B)(6) 2021. USER IS DOING FINE. NO FURTHER INVESTIGATION WAS FOUND NECESSARY. D2: PRODUCT CODE CHANGED TO QHJ.
Additional Manufacturer Narrative · 1
THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
ON SEPTEMBER 01ST 2021, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1456159 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM | QHJ | SENSEONICS INC. | 102096-67A | 00817491022349 | |
| 1456160 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM | QHJ | SENSEONICS INC. | 102096-67A | 00817491022349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Other |