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 |