MAUDE Adverse Event Report: CAREONE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fall (1848); Itching Sensation (1943); Rash (2033); Visual Impairment (2138); Burning Sensation (2146); Ulcer (2274)

Event Date 03/01/2018

Event Type  Injury  

Event Description

Caller stated she began to experience negative reactions after using device and starting medications.Symptoms include: physical imbalance, falling, rash over stomach and chest, erythema, itching, tiny ulcers under skin, burning sensation, and vision impairment.She is unable to perform activities of daily living and maintain her job.

• Brand Name: CAREONE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• MDR Report Key: 9903199
• MDR Text Key: 185938675
• Report Number: MW5093983
• Device Sequence Number: 2
• Product Code: FMI
• 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: 03/30/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention