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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERICHIP CORPORATION VERIMED PATIENT IDENTIFICATORVERICHIP IMPLANT

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VERICHIP CORPORATION VERIMED PATIENT IDENTIFICATOR VERICHIP IMPLANT   Back to Search Results
Event Date 07/27/2007
Event Type  Injury   Patient Outcome  Other
Event Description

I participated in a study. The verichip was implanted in my right arm in 2007 at approx 5:00 pm at: walk in med care. When inserted, the process was very painful but subsided after a few hours. On that dr even joked that he forgot to test the implant first to see if it works before the insertion. I found this situation very strange. What if it didn't work? what then? later on that evening, i felt sick with a possible low grade fever. In middle of night, i experienced discomfort in my right arm near insertion. Called clinic the next day and was relayed the message from dr to take 2 tylenols every 4 hrs and call him back on monday. I experienced pain as if the needle was still in my arm. This pain persisted thru the weekend. I called the clinic on monday and found out that dr only inserts the implant. By then, i wanted the implant removed from my arm. I received a phone call from dr, chief medical office and he possibly was concerned that the implant was improperly inserted into my arm, but wasn't sure. He told me then that nobody of the recipients of the implant wanted it removed and i was the first. I told him i found it hard to believe. He also explained that verichip corp does have any protocol in locating or removal of the implant as yet. They had no doctors trained to remove the implant, only insertion. The pain has been ongoing since the evening of that day - pinching sensation and throbbing on and off. I strongly believe the implant was incorrectly inserted or it has moved from the original insertion location on the top of my right arm to the lower part of my right arm almost near my arm pit. When the implant was removed, the surgeon had a difficult time removing the implant with the fluoroscopy machine because of the awkward position in the arm.

 
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Brand NameVERIMED PATIENT IDENTIFICATOR
Type of DeviceVERICHIP IMPLANT
Manufacturer (Section F)
VERICHIP CORPORATION
1690 south congress avenue
delray beach FL 33445
Manufacturer (Section D)
VERICHIP CORPORATION
1690 south congress avenue
delray beach FL 33445
Device Event Key941879
MDR Report Key962453
Event Key924087
Report NumberMW5004626
Device Sequence Number1
Product CodeNRV
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 12/03/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/28/2007
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

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