MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-06 for MICROWAVE DEVICE manufactured by .
[19052589]
Type of microwave stimulator being used by therapist who lives in downstairs apt. Waves are affecting bladder making it feel as if person in upstairs apartment has cystitis. Person in upstairs apartment complaining of waking in the early hours with pulse rate of over 100 per minute and b/p error to begin with, then 157/99. Normal b/p for this person is 115/70. Also feeling of tingling in lower leg extremity and fingers are very hot especially fingertips. After moving from the bedroom b/p returns to normal after 15 minutes. Patient very tired during day. -i am seeking advice as i have this problem coming from downstairs and do not know what is causing it. I am currently living in another country and have given my daughter's address in the us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004006 |
| MDR Report Key | 926139 |
| Date Received | 2007-10-06 |
| Date of Report | 2007-10-06 |
| Date of Event | 2007-10-05 |
| Date Added to Maude | 2007-10-19 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 |
| Generic Name | MICROWAVE DEVICE |
| Product Code | GZI |
| Date Received | 2007-10-06 |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 900921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-06 |