MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-03 for COLPOSCOPE NI manufactured by Grande Optical Products.
[20761916]
Co is mfg microscopes, including microscopes and colposcopes and selling them in the us without fda registration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003294 |
| MDR Report Key | 396465 |
| Date Received | 2002-04-03 |
| Date of Report | 2002-04-03 |
| Date Added to Maude | 2002-05-30 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | COLPOSCOPE |
| Generic Name | COLPOSCOPE |
| Product Code | HEX |
| Date Received | 2002-04-03 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 385493 |
| Manufacturer | GRANDE OPTICAL PRODUCTS |
| Manufacturer Address | 1111 SOUTH CAGE BLVD PHARR TX 78577 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-04-03 |