MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-10-20 for IPC-5000 manufactured by .
| Report Number | 1722684-1997-00003 |
| MDR Report Key | 127766 |
| Report Source | 06 |
| Date Received | 1997-10-20 |
| Date of Report | 1997-10-08 |
| Date of Event | 1997-09-27 |
| Date Mfgr Received | 1997-10-08 |
| Device Manufacturer Date | 1997-07-01 |
| Date Added to Maude | 1997-10-24 |
| 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 |
| Product Code | HGS |
| Date Received | 1997-10-20 |
| Model Number | IPC-5000 |
| Catalog Number | IPC-5000 |
| Lot Number | 970123 |
| ID Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 124995 |
| Baseline Brand Name | KOALA INTRAUTERINE PRESSURE CATHETER |
| Baseline Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Baseline Model No | IPC-5000 |
| Baseline Catalog No | IPC-5000 |
| Baseline ID | NA |
| Baseline Device Family | KOALA INTRAUTERINE PRESSURE CATHETERS |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K954955 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-10-20 |