MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-17 for CAYA NDC63704-020-01 US PATIENT # 5,771,900 manufactured by Kessel Medintim, Gmbh.
| Report Number | MW5089862 |
| MDR Report Key | 9082365 |
| Date Received | 2019-09-17 |
| Date of Report | 2019-09-13 |
| Date of Event | 2019-08-27 |
| Date Added to Maude | 2019-09-18 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAYA |
| Generic Name | DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES) |
| Product Code | HDW |
| Date Received | 2019-09-17 |
| Model Number | NDC63704-020-01 |
| Catalog Number | US PATIENT # 5,771,900 |
| Lot Number | 17U129L 10/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KESSEL MEDINTIM, GMBH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-17 |