MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-16 for * 13-0610 manufactured by Olympus Corporation Of The Americas.
[5041033]
While removing a rock from the patients left ear, the tip of the metal instrument broke off in the pt's ear. Ent md flushed child's ear out with antibiotic drops and gentle suction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4208869 |
| MDR Report Key | 4208869 |
| Date Received | 2014-10-16 |
| Date of Report | 2014-10-16 |
| Date of Event | 2014-10-02 |
| Report Date | 2014-10-16 |
| Date Reported to FDA | 2014-10-16 |
| Date Reported to Mfgr | 2014-10-29 |
| Date Added to Maude | 2014-10-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | APPLICATOR |
| Product Code | KCJ |
| Date Received | 2014-10-16 |
| Model Number | * |
| Catalog Number | 13-0610 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS CORPORATION OF THE AMERICAS |
| Manufacturer Address | 3500 CORPORATE PKWY PO BOX 610 CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-16 |