MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for EVERSENSE SENSOR 102096-67A FG-4200-00-301 manufactured by Senseonics Inc..
[185225423]
The sensor was successfully removed during the first removal attempt on (b)(6) 2020. Patient was doing good and no further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
[185225427]
On (b)(6) 2020,senseonics was made aware of an adverse event where patient could feel pain despite being injected with adequate amount of lidocaine and the sensor was removed on the first attempt made.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009862700-2020-00380 |
| MDR Report Key | 9885287 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-08-04 |
| Date Added to Maude | 2020-03-26 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 MONITOR SYSTEM |
| Product Code | QCD |
| Date Received | 2020-03-26 |
| Model Number | 102096-67A |
| Catalog Number | FG-4200-00-301 |
| Lot Number | WP06863 |
| Device Expiration Date | 2020-04-05 |
| 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 | 2020-03-26 |