MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-26 for ELEPHANT EAR WASHER manufactured by Flat Mop Corp.
[250715]
Tip of washer separated from the attached connection to washer bottle. Catheter-like tip lodged in ear canal and was removed by physician. Eardrum was perforated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 407722 |
| MDR Report Key | 407722 |
| Date Received | 2002-07-26 |
| Date of Report | 2002-07-16 |
| Date of Event | 2002-06-17 |
| Date Facility Aware | 2002-06-17 |
| Report Date | 2002-07-16 |
| Date Added to Maude | 2002-07-31 |
| 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 | 0 |
| 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 | ELEPHANT EAR WASHER |
| Generic Name | EAR WASHER TIP |
| Product Code | JYC |
| Date Received | 2002-07-26 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 396705 |
| Manufacturer | FLAT MOP CORP |
| Manufacturer Address | PO BOX 1717 ORANGE PARK FL 320671717 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-07-26 |