VERIMED PATIENT IDENTIFICATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-10 for VERIMED PATIENT IDENTIFICATOR manufactured by Verichip Corporation.

Event Text Entries

[769602] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5004626
MDR Report Key962453
Date Received2007-12-10
Date of Report2007-12-03
Date of Event2007-07-27
Date Added to Maude2008-01-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVERIMED PATIENT IDENTIFICATOR
Generic NameVERICHIP IMPLANT
Product CodeNRV
Date Received2007-12-10
Returned To Mfg2007-11-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagN
Date RemovedV
Device Sequence No1
Device Event Key941879
ManufacturerVERICHIP CORPORATION
Manufacturer Address1690 SOUTH CONGRESS AVENUE DELRAY BEACH FL 33445 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2007-12-10

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