MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M HYPODERMIC NEEDLE

Model Number 112120

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Customer reported: swelling and redness of the facial skin.Impact on patient: after treatment, the symptoms disappeared.Remedial action taken by the healthcare facility relevant to the care of the patient: medical check-up, antibiotic therapy, steroid therapy.

• Brand Name: SOL-M HYPODERMIC NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s wacker dr, suite 4100; chicago IL 60604
• Manufacturer (Section G): SOL-MILLENNIUM MEDICAL INC; 311 s wacker dr, suite 4100; chicago
• Manufacturer Contact: jarryd franklin
• MDR Report Key: 18483434
• MDR Text Key: 332550055
• Report Number: 3014312726-2024-00103
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 112120
• Device Lot Number: 02003053
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1