MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-06-02 for RA500 AUDIOMETER manufactured by Diagnostic Group Llc Dba Tremetrics.
[2015553]
Pt was under going a hearing test by employer. At the time of the test electrical maintenance or repair was taking place near by. An electrical power system anomaly occurred in the building where the test was being performed causing a high intensity spike in power. The pt claims to have experienced an explosive sound through the audiometer and into the left ear. The pt claims to have suffered permanent hearing damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2113281-2011-00001 |
| MDR Report Key | 2121306 |
| Report Source | 00 |
| Date Received | 2011-06-02 |
| Date of Report | 2011-06-01 |
| Date of Event | 2010-01-12 |
| Date Mfgr Received | 2011-05-15 |
| Date Added to Maude | 2011-06-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JIM ECKLEIN, DIRECTOR |
| Manufacturer Street | 7625 GOLDEN TRIANGLE DRIVE |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9522784436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RA500 AUDIOMETER |
| Generic Name | AUDIOMETER |
| Product Code | EWO |
| Date Received | 2011-06-02 |
| Model Number | RA500 |
| Catalog Number | RA500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTIC GROUP LLC DBA TREMETRICS |
| Manufacturer Address | EDEN PRAIRIE MN 55344 US 55344 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-06-02 |