MAUDE Adverse Event Report: MICRONEEDLING DEVICE; MICRO NEEDLE FOR GENERAL S/ PLASTIC

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Pain (1994); Reaction (2414)

Event Date 11/21/2017

Event Type  Injury  

Event Description

I had micro needling done to my forehead and face.After the procedure i had a severe headache pounding.I couldn't work and a week later am still in pain.I went to my doctor and she said it most likely was an adverse reaction to microneedling.I am still in so much pain.

• Brand Name: MICRONEEDLING DEVICE
• Type of Device: MICRO NEEDLE FOR GENERAL S/ PLASTIC
• MDR Report Key: 7079170
• MDR Text Key: 93812870
• Report Number: MW5073723
• Device Sequence Number: 1
• Product Code: GEY
• 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: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 66