MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-06-25 for FC1 FEMALE CONDOM manufactured by The Female Health Co..
[2761681]
User misused the fc1 female condom. User used fc1 for anal sex and was unable to remove the device (sheath and inner ring). User went to emergency room to have device removed. User released from emergency room (not hospitalized). The device was not torn. His tissues were not damaged. Minor irritation from the removal process.
Patient Sequence No: 1, Text Type: D, B5
[10119179]
Please contact (b)(6), if additional information required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1422723-2009-00001 |
| MDR Report Key | 2627380 |
| Report Source | 99 |
| Date Received | 2009-06-25 |
| Date of Report | 2009-06-24 |
| Date of Event | 2009-06-22 |
| Date Mfgr Received | 2009-06-22 |
| Date Added to Maude | 2012-06-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 515 NORTH STATE ST. SUITE 2225 |
| Manufacturer City | CHICAGO IL 60611 |
| Manufacturer Country | US |
| Manufacturer Postal | 60611 |
| Manufacturer Phone | 3125959123 |
| Manufacturer Street | CORONATION ROAD PARK ROYAL; UNIT ONE |
| Manufacturer City | LONDON NW107QP |
| Manufacturer Country | UK |
| Manufacturer Postal Code | NW10 7QP |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FC1 FEMALE CONDOM |
| Generic Name | FCI |
| Product Code | MBU |
| Date Received | 2009-06-25 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE FEMALE HEALTH CO. |
| Manufacturer Address | CHICAGO IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-06-25 |