FDA Adverse Event
Injury
Summary report: N
EVERSENSE SENSOR
MDR report key: 14804639
·
Received June 24, 2022
Report
- Report Number
- 3009862700-2022-00108
- Event Type
- Injury
- Date Received
- June 24, 2022
- Date of Event
- May 20, 2022
- Report Date
- May 25, 2022
- 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
THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 0
NO INFORMATION REGARDING NEXT REMOVAL ATTEMPT COULD BE GATHERED DUE TO LACK OF RESPONSE FROM THE USER DESPITE MAKING SEVERAL FOLLOW UP ATTEMPTS. NO FURTHER INVESTIGATION WAS FOUND NECESSARY.
Description of Event or Problem · 0
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR FROM THE USERS ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1072825 | EVERSENSE SENSOR | EVERSENSE CONTINUOUS GLUCOSE MONITOR | QHJ | SENSEONICS INC. | 102096-67A | WP08507 | 00817491022349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male |