MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 1998-12-14 for FETALGARD 3000 IP10-E-104 UNK manufactured by Analogic Corporation.
| Report Number | 1219601-1998-00002 |
| MDR Report Key | 203012 |
| Report Source | 06,08 |
| Date Received | 1998-12-14 |
| Date of Event | 1998-11-03 |
| Date Mfgr Received | 1998-11-13 |
| Device Manufacturer Date | 1996-06-01 |
| Date Added to Maude | 1998-12-23 |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FETALGARD 3000 |
| Product Code | HEL |
| Date Received | 1998-12-14 |
| Model Number | IP10-E-104 |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 193548 |
| Manufacturer | ANALOGIC CORPORATION |
| Manufacturer Address | 360 AUDUBON ROAD WAKEFIELD MA 01880 US |
| Baseline Brand Name | FETALGUARD 3000 |
| Baseline Generic Name | FETAL MONITOR |
| Baseline Model No | IP10-E-104 |
| Baseline Catalog No | UNK |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-12-14 |