MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 1999-08-23 for DEVICE 2 DOMINANT 0561406 * manufactured by Medela, Ag Medical Equipment.
| Report Number | 1419937-1999-00003 |
| MDR Report Key | 238694 |
| Report Source | 06,08 |
| Date Received | 1999-08-23 |
| Date of Event | 1999-07-06 |
| Date Mfgr Received | 1999-07-22 |
| Device Manufacturer Date | 1997-02-01 |
| Date Added to Maude | 1999-09-08 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEVICE 2 DOMINANT |
| Generic Name | DEVICE 2 VACUUM EXTRACTOR, OBSTETRICAL |
| Product Code | FHF |
| Date Received | 1999-08-23 |
| Model Number | 0561406 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 231298 |
| Manufacturer | MEDELA, AG MEDICAL EQUIPMENT |
| Manufacturer Address | LATTICHSTRASSE 4 BAAR SZ 6340 |
| Baseline Brand Name | DOMINANT |
| Baseline Generic Name | SUCTION PUMP |
| Baseline Model No | 0561406 |
| Baseline Catalog No | 0561406 |
| Baseline ID | NA |
| Baseline Device Family | SUCTION PUMPS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K830012 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-08-23 |