MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-08-09 for ZODIAC 901 manufactured by Madsen Electronics.
[17173530]
Ni
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 63647-2000-00001 |
| MDR Report Key | 290792 |
| Report Source | 04 |
| Date Received | 2000-08-09 |
| Date of Report | 2000-07-25 |
| Date of Event | 1999-07-15 |
| Date Mfgr Received | 2000-07-25 |
| Date Added to Maude | 2000-08-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | MAARKAERVEJ 2A |
| Manufacturer City | TAASTRUP DK-2630 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2630 |
| Manufacturer Phone | 2111333 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZODIAC 901 |
| Generic Name | MIDDLE EAR ANALYZER |
| Product Code | ETY |
| Date Received | 2000-08-09 |
| Model Number | ZODIAC 901 |
| Catalog Number | NI |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 281435 |
| Manufacturer | MADSEN ELECTRONICS |
| Manufacturer Address | MAARKAERVEJ 2A TAASTRUP DA DK-2630 |
| Baseline Brand Name | ZODIAC 901 |
| Baseline Generic Name | MIDDLE EAR ANALYZER |
| Baseline Model No | ZODIAC 901 |
| Baseline Catalog No | NI |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-08-09 |