• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT LABORATORIES FREESTYLE LIBRE SENSOR SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Scarring (2061); Swelling (2091); Reaction (2414); Caustic/Chemical Burns (2549)
Event Date 11/21/2019
Event Type  Injury  
Event Description
Abbott freestyle libre sensor causing adverse skin reactions. Red and broken blistered skin, itching, scars. Mfr refuse to help identify possible solutions. I have marks on my arms that have not gone away. The sensor adhesive has got to be the issue. Chemical burns and scars. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFREESTYLE LIBRE SENSOR
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
ABBOTT LABORATORIES
MDR Report Key9368976
MDR Text Key167853367
Report NumberMW5091268
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 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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: 11/22/2019 Patient Sequence Number: 1
-
-