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

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).

• Brand Name: FREESTYLE LIBRE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT LABORATORIES
• MDR Report Key: 9368976
• MDR Text Key: 167853367
• Report Number: MW5091268
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 99