MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-11 for VERICHIP TRACKING DEVICE (POSITIVEID) manufactured by Verichip Corp.
[18638304]
Pt called to report adverse events regarding a verichip device, which pt says was inserted into his arm without his consent. Pt stated he can see the verichip implant bulging out of his arm, and says it's painful. Pt said he was in a (b)(6) for a bladder infection, when the device was unknowingly implanted in his arm. Now, p states that the tracking verichip is causing both pain and involuntary muscle twitching. Pt said the device is implanted in soldiers and pts at va hospitals to keep track of them. Pt said he has been told by multiple doctors and va hospitals that there isn't a device implanted in his arm, instead it's a blood clot and will go away on its own. Pt says it's imperative he gets this device removed from his arm, and that he's worried for his health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040678 |
| MDR Report Key | 4515942 |
| Date Received | 2015-02-11 |
| Date of Report | 2015-02-11 |
| Date of Event | 2014-11-01 |
| Date Added to Maude | 2015-02-18 |
| 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 | 0 |
| 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 |
| Brand Name | VERICHIP TRACKING DEVICE (POSITIVEID) |
| Generic Name | IMPLANTABLE RADIO FREQUENCY TRANSPONDER SYSTEM |
| Product Code | NRV |
| Date Received | 2015-02-11 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERICHIP CORP |
| Manufacturer Address | 1690 SOUTH CONGRESS AVE DELRAY BEACH FL 33445 US 33445 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-02-11 |