MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-10 for STARKEY RIC 312 manufactured by Starkey.
[3135902]
Starkey ric 312 cable has broken where it joins the hearing instrument. This is the third one i have gotten in the last 8 months that has done this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028978 |
| MDR Report Key | 2964172 |
| Date Received | 2013-02-10 |
| Date of Report | 2013-02-10 |
| Date of Event | 2013-02-10 |
| Date Added to Maude | 2013-02-19 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| 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 | STARKEY RIC 312 |
| Generic Name | HEARING AID |
| Product Code | OSM |
| Date Received | 2013-02-10 |
| Returned To Mfg | 2013-02-11 |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STARKEY |
| Manufacturer Address | EDEN PRAIRIE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-10 |