MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-04-24 for THERMOLYNE DB12215E manufactured by .
| Report Number | 1950043-1997-00001 |
| MDR Report Key | 87868 |
| Report Source | 06 |
| Date Received | 1997-04-24 |
| Date of Event | 1997-02-18 |
| Date Mfgr Received | 1997-03-07 |
| Device Manufacturer Date | 1978-01-01 |
| Date Added to Maude | 1997-05-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOLYNE |
| Generic Name | BLOOD BANK DRI-BATH |
| Product Code | JRG |
| Date Received | 1997-04-24 |
| Model Number | DB12215E |
| Catalog Number | DB12215E |
| Lot Number | NA |
| ID Number | SERIES 250 |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 72810 |
| Baseline Brand Name | THERMOLYNE |
| Baseline Generic Name | BLOOD BANK DRI-BATH |
| Baseline Model No | DB12215E |
| Baseline Catalog No | DB12215E |
| Baseline ID | * |
| Baseline Device Family | DRI-BATHS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-04-24 |