MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-13 for CLOSED-LOOP CALORIC IRRIGATOR DA200 manufactured by Grams Medical Products.
[15184]
When attempting to begin caloric irrigation on right ear, cold water, pt complained of pain. Rptr stopped test, then noticed blood at right ear. Ear continued to bleed for several hrs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 20708 |
| MDR Report Key | 20708 |
| Date Received | 1995-03-13 |
| Date of Event | 1995-02-23 |
| Date Facility Aware | 1995-02-24 |
| Report Date | 1995-03-13 |
| Date Added to Maude | 1995-03-27 |
| 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 |
| Reporter Occupation | AUDIOLOGIST |
| 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 | CLOSED-LOOP CALORIC IRRIGATOR |
| Generic Name | CLOSED-LOOP CALORIC IRRIGATOR |
| Product Code | JYH |
| Date Received | 1995-03-13 |
| Model Number | DA200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 20592 |
| Manufacturer | GRAMS MEDICAL PRODUCTS |
| Manufacturer Address | COSTA MESA CA 92627 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 1995-03-13 |