MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-11-12 for UNK manufactured by Miltex Instrument Co, Inc..
Report Number | 2431021-1998-00011 |
MDR Report Key | 196896 |
Report Source | 05,06 |
Date Received | 1998-11-12 |
Date of Report | 1998-11-11 |
Date of Event | 1998-09-23 |
Date Mfgr Received | 1998-11-10 |
Date Added to Maude | 1998-11-17 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
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 | EAX |
Date Received | 1998-11-12 |
Catalog Number | UNK |
Lot Number | UNK |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 191300 |
Manufacturer | MILTEX INSTRUMENT CO, INC. |
Manufacturer Address | 6 OHIO DR - CB 5006 LAKE SUCCESS NY 110420006 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1998-11-12 |