MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-06 for NI 71515 manufactured by Medi-source, Inc..
[17487657]
Slides are dirty, have a greasy film and the edges are chipped and rough. The slides are unacceptable for making blood differential smears. Poor workmanship.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002320 |
| MDR Report Key | 183289 |
| Date Received | 1998-08-06 |
| Date of Report | 1998-05-27 |
| Date Added to Maude | 1998-08-21 |
| 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 | NI |
| Generic Name | MICROSCOPE SLIDES, FROSTED |
| Product Code | KEW |
| Date Received | 1998-08-06 |
| Model Number | 71515 |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | 6640000744191 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 178195 |
| Manufacturer | MEDI-SOURCE, INC. |
| Manufacturer Address | 50 GORDON DR. SYOSSET NY 11791 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-08-06 |