MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for FREESTYLE LIBRE 14 DAY GLUCOSE SENSOR 71940-01 manufactured by Abbott Diabetes Care Inc..
[185050547]
Blistering and severe irritation at the attachment site of the 14 day freestyle libre glucose sensor. This has been happening since they switched me to the 14 day sensor from the 10 day sensor. I get severe itching while wearing the sensor and then when removed there is a severly irritated, red and inflamed mark that last 5 to 6 weeks after removal of the sensor. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093910 |
| MDR Report Key | 9877617 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-03-20 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREESTYLE LIBRE 14 DAY GLUCOSE SENSOR |
| Generic Name | SENSOR, GLUCOSE, INVASIVE |
| Product Code | MDS |
| Date Received | 2020-03-24 |
| Model Number | FREESTYLE LIBRE 14 DAY |
| Catalog Number | 71940-01 |
| Lot Number | 191202P |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETES CARE INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-24 |