FREESTYLE LIBRE 14 DAY Adverse Event — Injury (MDR 2954323-2020-02987)
FREESTYLE LIBRE 14 DAY Adverse Event — Injury (MDR 2954323-2020-02987) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FREESTYLE LIBRE 14 DAY; Generic name: FLASH GLUCOSE MONITORING SYSTEM; Manufacturer: ABBOTT DIABETES CARE INC.
| Device | FREESTYLE LIBRE 14 DAY |
|---|---|
| Generic name | FLASH GLUCOSE MONITORING SYSTEM |
| Manufacturer | ABBOTT DIABETES CARE INC |
| Report number | 2954323-2020-02987 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | AT THIS TIME, PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT. THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE REPORTED COMPLAINT IS RELATED TO SKIN IRRITATION OR AN ALLERGIC REACTION TO THE PATCH ADHESIVE OF THE FREESTYLE LIBRE SENSOR. DHRS (DEVICE HISTORY REVIEW) FOR THE FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE |
| Source | openFDA MAUDE (device adverse events) |
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