MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-25 for REALITY * manufactured by Female Health Co..
[18189594]
Based on the info provided in the report, it is not possible to conduct an investigation and respond to questions 1-3. The female condom has an outer ring that is intended to cover the labia and to prevent the entire condom from entering the vagina during intercourse. On occasion, consumers may need to add add'l lubricant to the condom to prevent the penis from pushing the outer ring into the vagina. The directions for use address this possibility and alert the consumer to use more lubricant if the outer ring if pushed into the vagina.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001928 |
| MDR Report Key | 100723 |
| Date Received | 1997-06-25 |
| Date of Report | 1997-04-24 |
| Date Added to Maude | 1997-06-27 |
| 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 | REALITY |
| Generic Name | FEMALE CONDOM |
| Product Code | MBU |
| Date Received | 1997-06-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 99234 |
| Manufacturer | FEMALE HEALTH CO. |
| Manufacturer Address | 875 N. MICHIGAN AVE. SUITE 3660 CHICAGO IL 60611 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-25 |