MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-09-12 for INCSTARCORP CMV UVE KIT 24300 manufactured by Inc Star Corp..
[28504]
Decreased staining intensity of positive control and samples using cmv-vue kit. Kit contains instructions and materials for the qualitative detection of early structural protein of cmv.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2182595-1996-09001 |
MDR Report Key | 41027 |
Report Source | 06 |
Date Received | 1996-09-12 |
Date of Report | 1996-09-06 |
Date of Event | 1996-09-06 |
Date Mfgr Received | 1996-09-06 |
Device Manufacturer Date | 1996-05-01 |
Date Added to Maude | 1996-10-08 |
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 |
Reporter Occupation | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Remedial Action | RL |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | INCSTARCORP CMV UVE KIT |
Generic Name | IN VITRO DIAGNOSTIC |
Product Code | LIN |
Date Received | 1996-09-12 |
Model Number | NA |
Catalog Number | 24300 |
Lot Number | 315676, 315676A |
ID Number | NA |
Device Expiration Date | 1997-05-07 |
Operator | OTHER |
Device Availability | Y |
Device Age | * |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 42112 |
Manufacturer | INC STAR CORP. |
Manufacturer Address | 1990 INDUSTRIAL BLVD STILLWATER MN 55082 US |
Baseline Brand Name | INSTAR CORP CMV-VUE |
Baseline Generic Name | CMV-VUE DIAGNOSTIC KIT |
Baseline Model No | NA |
Baseline Catalog No | 24300 |
Baseline ID | NA |
Baseline Device Family | IN VITRO DIAGNOSTIC |
Baseline Shelf Life Contained | Y |
Baseline Shelf Life [Months] | 12 |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K921616 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1996-09-12 |