MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-12-16 for manufactured by .
| Report Number | 2939576-1998-00008 |
| MDR Report Key | 201949 |
| Report Source | 07 |
| Date Received | 1998-12-16 |
| Date of Event | 1998-03-31 |
| Date Mfgr Received | 1998-10-26 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 1998-12-17 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | RECALL # Z-491-8 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | FLF |
| Date Received | 1998-12-16 |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 196152 |
| Baseline Brand Name | PLAZLYTE STERILIZER |
| Baseline Generic Name | GAS STERILIZER |
| Baseline Model No | ABT 1.0 |
| Baseline Catalog No | PL006-01-02 |
| Baseline ID | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K905119 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-12-16 |