MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-28 for UNK NI manufactured by Eng Scientific, Inc.
[19495977]
All organisms stained with this kit appear as gram negative organisms. This kit is unfit for use in a medical laboratory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002330 |
| MDR Report Key | 187331 |
| Date Received | 1998-08-28 |
| Date of Report | 1998-05-20 |
| Date Added to Maude | 1998-09-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | GRAM STAIN KIT |
| Product Code | JTS |
| Date Received | 1998-08-28 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | 794230 |
| ID Number | 6550-00-261-9053 |
| Device Expiration Date | 1999-03-01 |
| Operator | UNKNOWN |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 182085 |
| Manufacturer | ENG SCIENTIFIC, INC |
| Manufacturer Address | PO BOX 1589 82 INDUSTRIAL EAST CLIFTON NJ 07012 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-08-28 |