MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-21 for VAGINAL * 8310 manufactured by Galenica, Inc..
[18191861]
Latch does not stay engaged after inserting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021256 |
| MDR Report Key | 319055 |
| Date Received | 2001-02-21 |
| Date Added to Maude | 2001-03-08 |
| 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 | VAGINAL |
| Generic Name | SPECULUM |
| Product Code | HDF |
| Date Received | 2001-02-21 |
| Model Number | * |
| Catalog Number | 8310 |
| Lot Number | * |
| ID Number | PRODUCT NO 8310 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 308604 |
| Manufacturer | GALENICA, INC. |
| Manufacturer Address | 12805 RUE DE PARC MARAHEL, QUEBEC CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-02-21 |