MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-05 for FC FEMALE CONDOM * manufactured by The Female Health Co..
[20888195]
Customer used female condom and noted outer ring pulled inside vagina during use. Two months later, after suffering a light period in the interim, pt went to see their physician because if "hemmorage". Physician advised that pt had miscarried. Customer has two children.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1422723-2001-00001 |
| MDR Report Key | 336336 |
| Date Received | 2001-06-05 |
| Date of Report | 2001-06-04 |
| Date of Event | 2001-05-09 |
| Date Added to Maude | 2001-06-11 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FC FEMALE CONDOM |
| Generic Name | FEMALE CONDOM BARRIER DEVICE |
| Product Code | MBU |
| Date Received | 2001-06-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 2447 |
| ID Number | * |
| Device Expiration Date | 2005-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 325640 |
| Manufacturer | THE FEMALE HEALTH CO. |
| Manufacturer Address | 875 N MICHIGAN AVE #3660 CHICAGO IL 60611 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-06-05 |