MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-10-21 for manufactured by .
| Report Number | 2431314-1998-00001 |
| MDR Report Key | 193188 |
| Report Source | 00 |
| Date Received | 1998-10-21 |
| Date of Event | 1997-05-06 |
| Date Mfgr Received | 1998-10-13 |
| Date Added to Maude | 1998-10-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | IYT |
| Date Received | 1998-10-21 |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 182994 |
| Baseline Brand Name | PULMONEX XENON SYSTEM |
| Baseline Generic Name | NUCLEAR MEDICINE LUNG SCAN |
| Baseline Model No | 130-500 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-10-21 |