MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-09 for TREMETRICS RA300 RA300+ 8121536 manufactured by Tremetrics.
[19312187]
It was reported that a tremetrics ra300 audiometer caused hearing loss 1 week after a normal hearing test. The pt did not complain of pain or hearing loss during or after the exam. The pt did complain of a loud tone, however, the clinician re-explained the test procedure and the test was completed without any further complication.
Patient Sequence No: 1, Text Type: D, B5
[19631730]
The device was returned and device history records were reviewed. All mfg and quality assurance testing was carried out in accordance with standard procedure, and the device met specification at the time of release. In addition, further testing was conducted on the returned device and all specifications were met.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2113281-2015-00001 |
| MDR Report Key | 4908282 |
| Report Source | 06 |
| Date Received | 2015-07-09 |
| Date of Report | 2015-06-08 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-06-15 |
| Device Manufacturer Date | 2014-05-14 |
| Date Added to Maude | 2015-07-14 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. KEVIN LAM |
| Manufacturer Street | 10395 WEST 70TH ST. |
| Manufacturer City | EDEN PRAIRIE MN 55344 |
| Manufacturer Country | US |
| Manufacturer Postal | 55344 |
| Manufacturer Phone | 6128010842 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TREMETRICS RA300 |
| Generic Name | AUDIOMETER |
| Product Code | EWO |
| Date Received | 2015-07-09 |
| Returned To Mfg | 2015-06-16 |
| Model Number | RA300+ |
| Catalog Number | 8121536 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TREMETRICS |
| Manufacturer Address | 10395 WEST 70TH STREET EDEN PRAIRIE MN 55344 US 55344 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-09 |