MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-06-23 for RA500 AUDIOMETER manufactured by Diagnostic Group, Llc.
[1611073]
A healthy patient, with no prior hearing issues, entered a "hearing chamber", had headphones placed on and underwent a hearing test. The patient claims to have experienced a loud sound through his left ear. Patient claims to have suffered a hearing loss.
Patient Sequence No: 1, Text Type: D, B5
[8556453]
Literature searches regarding exposure to loud sounds, including the occupational safety and health administration (osha) and national institute for occupational safety and health (niosh) guidelines, show that given a 120db, 50ms noise that would fall within the guidelines for allowable exposure. Furthermore, a brief exposure to a noise of 120db spl at 1000 hz would have no permanent effect on hearing sensitivity and is unlikely to cause even a temporary threshold shift (tts).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2113281-2010-00001 |
| MDR Report Key | 1734655 |
| Report Source | 00 |
| Date Received | 2010-06-23 |
| Date of Report | 2010-05-06 |
| Date of Event | 2009-08-05 |
| Date Mfgr Received | 2010-03-27 |
| Date Added to Maude | 2010-06-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 7625 GOLDEN TRIANGLE DRIVE |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 9522784457 |
| 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 | 2010-06-23 |
| Model 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 |
| Manufacturer Address | EDEN PRAIRIE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-06-23 |