MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-08-14 for manufactured by .
| Report Number | 1718873-1997-00001 |
| MDR Report Key | 138144 |
| Report Source | 05 |
| Date Received | 1997-08-14 |
| Date of Event | 1997-04-11 |
| Date Mfgr Received | 1997-07-09 |
| Date Added to Maude | 1997-12-17 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | KXO |
| Date Received | 1997-08-14 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 85578 |
| Baseline Brand Name | INTRAN PLUS |
| Baseline Generic Name | IUPC |
| Baseline Model No | IUP-400 |
| Baseline Catalog No | IUP-400 |
| Baseline ID | NA |
| Baseline Device Family | INTRAN |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K955443 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-14 |