MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for CAYA NDC 63704-020-01 manufactured by Kessel Medintim Gmbh.
[139541698]
I was prescribed a caya diaphragm, and i noticed an error on the packing. The outer box states, "leave in the vaginal for longer than 24 hours without interruption. " the packaging insert, however, states in highlighted, bold text: "the caya diaphragms should never be left in the vagina for longer than 24 hours [underline] without interruption. Wearing it for longer, uninterrupted periods can promote bacterial growth in the vagina. These bacteria could lead to toxic shock syndrome. " please ask the makers of caya to fix the verbiage on the outer box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085042 |
| MDR Report Key | 8436589 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-18 |
| Date of Event | 2019-03-17 |
| Date Added to Maude | 2019-03-20 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAYA |
| Generic Name | DIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES) |
| Product Code | HDW |
| Date Received | 2019-03-19 |
| Model Number | NDC 63704-020-01 |
| Lot Number | 17U107L04/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KESSEL MEDINTIM GMBH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-19 |