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 |