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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.

DeviceFREESTYLE LIBRE 14 DAY
Generic nameFLASH GLUCOSE MONITORING SYSTEM
ManufacturerABBOTT DIABETES CARE INC
Report number2954323-2020-02987
Event typeInjury
Product problemN
Date received2020-04-28
Report sourceCONSUMER
NarrativeAT 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
SourceopenFDA MAUDE (device adverse events)

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