MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-07 for ROSEN ROUND KNIFE WEAPON MICRO EAR INSTRUMENT 10-610-25 manufactured by Spiggle & Theis Medizintechnik Gmbh / Jedmed.
| Report Number | MW5090245 |
| MDR Report Key | 9166186 |
| Date Received | 2019-10-07 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-09-27 |
| Date Added to Maude | 2019-10-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROSEN ROUND KNIFE WEAPON MICRO EAR INSTRUMENT |
| Generic Name | KNIFE, EAR |
| Product Code | JYO |
| Date Received | 2019-10-07 |
| Model Number | 10-610-25 |
| Lot Number | 045/04-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPIGGLE & THEIS MEDIZINTECHNIK GMBH / JEDMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-07 |