MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-05 for LIFESTYLES PREMIUM manufactured by Ansell Healthcare Inc.
[222249]
The consumer stated that three of the twelve condoms from the box failed during use. They appeared to have been too thin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003031 |
| MDR Report Key | 341748 |
| Date Received | 2001-07-05 |
| Date of Report | 2001-07-05 |
| Date of Event | 2001-05-15 |
| Date Added to Maude | 2001-07-17 |
| 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 |
| 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 | LIFESTYLES PREMIUM |
| Generic Name | LUBRICATED CONDOMS WITH NONOXYNOL |
| Product Code | LTZ |
| Date Received | 2001-07-05 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 331079 |
| Manufacturer | ANSELL HEALTHCARE INC |
| Manufacturer Address | 1500 INDUSTRIAL RD DOTHAN AL 36303 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-07-05 |