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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABATES CARE INC. FREESTYLE LIBRE 14 DAY SENSOR SENSOR, GLUCOSE, INVASIVE

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ABBOTT DIABATES CARE INC. FREESTYLE LIBRE 14 DAY SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Lot Number 190724P
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Local Reaction (2035); Burn, Thermal (2530)
Event Date 09/15/2019
Event Type  Injury  
Event Description
Libre freestyle 14 day patch. Slid off due to the burns underneath the path. Water blisters stopped the glue from keeping the patch on. When removed the skin was covered in water blisters and some of the skin came off. Very painful and burning. Skin reaction burning. Fda safety report id # (b)(4).
 
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Brand NameFREESTYLE LIBRE 14 DAY SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABATES CARE INC.
MDR Report Key9106430
MDR Text Key159850460
Report NumberMW5089976
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Lot Number190724P
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/23/2019 Patient Sequence Number: 1
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