MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-06-17 for MIRA OS4081 TRANSILLUMINATING DIATHERMY HANDLE manufactured by Mira, Inc..
[1341327]
Diathermy handle remains activated without the user activating the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218813-2010-00006 |
| MDR Report Key | 1735031 |
| Report Source | 08 |
| Date Received | 2010-06-17 |
| Date Mfgr Received | 2010-02-10 |
| Date Added to Maude | 2010-11-22 |
| 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 Street | 414 QUAKER HIGHWAY |
| Manufacturer City | UXBRIDGE MA 01527 |
| Manufacturer Country | US |
| Manufacturer Postal | 01527 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIRA OS4081 TRANSILLUMINATING DIATHERMY HANDLE |
| Generic Name | NONE |
| Product Code | HQR |
| Date Received | 2010-06-17 |
| Returned To Mfg | 2010-02-10 |
| Model Number | OS4081 |
| Catalog Number | OS4081 |
| Lot Number | HV |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIRA, INC. |
| Manufacturer Address | UXBRIDGE MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-17 |