MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-25 for EVERSENSE SENSOR 102096-67A FG-4200-00-301 manufactured by Senseonics Inc..
[185225698]
The patient visited emergency room on (b)(6) 2020 and the sensor popped out at emergency room and it was discarded. The patient was prescribed with doxcycline. No other treatment at the emergency room. He was discharged within an hour and half. User reported that he is doing fine and the area is definitely much better than it was. Incision is still open but starting to heal. No further investigation can be performed since there was no material returned.
Patient Sequence No: 1, Text Type: N, H10
[185225699]
On (b)(6) 2020,senseonics was made aware of an adverse event where reports of redness at the insertion site and over the weekend the redness and swelling worsened so he went to the emergency room where the sensor popped out of his arm. Site was covered with a band aid and he instructed to stop the antibiotic he was taking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009862700-2020-00279 |
| MDR Report Key | 9879867 |
| Report Source | CONSUMER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-25 |
| 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 MONITORING SYSTEM |
| Product Code | QCD |
| Date Received | 2020-03-25 |
| Model Number | 102096-67A |
| Catalog Number | FG-4200-00-301 |
| Lot Number | WP06637 |
| 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 | 1. Hospitalization | 2020-03-25 |