MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-04 for AVANTI NON-LATEX CONDOM 0582 manufactured by Ssl International, Plc..
[258011]
Consumer purchased a package of the co's durex avanti condoms. Allegedly 2 broke from a package of 6. The consumer had emergency contraception.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1065445-2002-00010 |
| MDR Report Key | 420789 |
| Date Received | 2002-10-04 |
| Date of Report | 2002-10-04 |
| Date Facility Aware | 2002-10-03 |
| Report Date | 2002-10-04 |
| Date Reported to FDA | 2002-10-04 |
| Date Reported to Mfgr | 2002-10-04 |
| Date Added to Maude | 2002-10-09 |
| 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 | AVANTI NON-LATEX CONDOM |
| Generic Name | CONDOM |
| Product Code | MOL |
| Date Received | 2002-10-04 |
| Model Number | NA |
| Catalog Number | 0582 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 409835 |
| Manufacturer | SSL INTERNATIONAL, PLC. |
| Manufacturer Address | TOFT HALL KNUTSFORD, CHESHIRE UK WA16 9PD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2002-10-04 |