VERICHIP HUMAN MICROCHCIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-28 for VERICHIP HUMAN MICROCHCIP manufactured by Boca Raton.

Event Text Entries

[1174869] I have the verichip human implantable microchip in my right arm. I was told when i got it 2 years ago, that if i was unable to speak or "knocked out", an emergency room would scan my arm and be able to obtain my health info online. I got the microchip because, i have ankylosing spondalitis and should not be intubated. When i got it, the company told me it could be "easily removed" if i decided i didn't want it in the future. No hospitals are scanning arms for the microchip, so it is completely worthless. The company will not remove it unless it becomes infected and the doctor they had put it in my arm says he is not trained to take it out and i would have to go to a surgeon. How can they train physicians to put something in our body, yet not teach them how to remove it? I went to a surgeon and the surgeon said it would be more dangerous to remove it than just to leave it in. There are many of us around the country who would like to have this removed, but it is not "easy". The firm is not living up to the fda claim they gave us. It is worthless! What can we do? Thank you very much. Dates of use: 2007 - 2009. Diagnosis or reason for use: neck is fused. Event abated after use stopped or dose reduced? No. Event reappeared after reintroduction? #1 and #2: no.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5012900
• MDR Report Key: 1490748
• Date Received: 2009-09-28
• Date of Report: 2009-09-28
• Date of Event: 2009-09-28
• Date Added to Maude: 2009-10-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VERICHIP HUMAN MICROCHCIP
• Generic Name: VERICHIP
• Product Code: NRV
• Date Received: 2009-09-28
• ID Number: DO NOT KNOW
• Operator: LAY USER/PATIENT
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BOCA RATON
• Manufacturer Address: BOCA RATON FL US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2009-09-28