MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-22 for AQUASTAR IRRIGATOR manufactured by Micromedical.
[17375310]
Patient having audiogram, equipment generated too hot of water being irrigated into ear. Patient complained test was stopped. Patient had no further complaints. Equipment removed from service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014895 |
| MDR Report Key | 1617150 |
| Date Received | 2010-02-22 |
| Date of Report | 2010-02-22 |
| Date of Event | 2010-02-09 |
| Date Added to Maude | 2010-03-22 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUASTAR IRRIGATOR |
| Generic Name | IRRIGATOR |
| Product Code | LXV |
| Date Received | 2010-02-22 |
| Returned To Mfg | 2010-02-12 |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROMEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-22 |