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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE LIMITED FREESTYLE LIBRE 14 DAY SENSOR; SENSOR, GLUCOSE, INVASIVE
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ABBOTT DIABETES CARE LIMITED FREESTYLE LIBRE 14 DAY SENSOR; SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number 71733-01
Device Problems Loss of or Failure to Bond (1068); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Patient Problems Local Reaction (2035); Skin Irritation (2076); Skin Inflammation (2443)
Event Date 12/31/2019
Event Type  Injury  
Event Description
Required dr visit with meds.Use of freestyle libre 14 day sensor caused severe contact dermatitis, with layer of skin damaged and sensor falling off with skin after 7 days use.Used adhesive barrier skin tac as recommended by mfr and it just made it worse.I required medical care and a week of antibiotic pills and cream to prevent infection from the open wound.Notified mfr and was shrugged off with "lots of people are allergic to our product." nowhere do i see it says "may blister the skin causing open wound the size of half dollar coin." fda safety report id# (b)(4).
 
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Brand Name
FREESTYLE LIBRE 14 DAY SENSOR
Type of Device
SENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT DIABETES CARE LIMITED
MDR Report Key9559240
MDR Text Key174124829
Report NumberMW5092070
Device Sequence Number1
Product Code MDS
UDI-Device Identifier00357599000059
UDI-Public(01)00357599000059(10)2.2.2.1098
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number71733-01
Device Catalogue Number71733-01
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
Patient Weight61
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