MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-16 for EVERSENSE SENSOR 102096-67A FG-4200-00-301 manufactured by Senseonics Inc..
[183753098]
This mdr is result of a retrospective review of complaints. User was not happy with the scarring and removal procedure. As per the user request the sensor was successfully removed on b)(6) 2020. No additional investigation found necessary.
Patient Sequence No: 1, Text Type: N, H10
[183753099]
On b)(6) 2020,senseonics was made aware of an adverse event that user was not happy with the removal process and that he had scarring at the insertion site due to the procedure; he wanted the sensor out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009862700-2020-00209 |
| MDR Report Key | 9837000 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-16 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-05-09 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. VALLIKANNU SOMASUNDARAM |
| Manufacturer Street | 20451 SENECA MEADOWS PARKWAY |
| Manufacturer City | GERMANTOWN, MD |
| Manufacturer Country | US |
| Manufacturer G1 | SENSEONICS INC. |
| Manufacturer Street | 20451 SENECA MEADOWS PARKWAY |
| Manufacturer City | GERMANTOWN,, MD |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVERSENSE SENSOR |
| Generic Name | EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Product Code | QCD |
| Date Received | 2020-03-16 |
| Model Number | 102096-67A |
| Catalog Number | FG-4200-00-301 |
| Lot Number | WP06329 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SENSEONICS INC. |
| Manufacturer Address | 20451 SENECA MEADOWS PARKWAY GERMANTOWN,, MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |