MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-29 for LIFESTYLES, LUBRICATED WITH NONOXYNOL-9 * manufactured by Ansell Corp. Ansell Healthcare.
[18485185]
Person reports that condom broke during sexual intercourse. This happened again with same batch of condoms. Also ten other people complained of breakage after getting condoms from facility. Only 200 had been distributed at that time. These people had received info on the correct usage of condoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009822 |
| MDR Report Key | 36338 |
| Date Received | 1996-08-29 |
| Date of Report | 1996-08-21 |
| Date of Event | 1996-07-20 |
| Date Added to Maude | 1996-09-05 |
| 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, LUBRICATED WITH NONOXYNOL-9 |
| Generic Name | CONDOM |
| Product Code | LTZ |
| Date Received | 1996-08-29 |
| Returned To Mfg | 1996-08-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 1999-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 37757 |
| Manufacturer | ANSELL CORP. ANSELL HEALTHCARE |
| Manufacturer Address | MERIDIAN CTR 3 INDUSTRIAL WAY EATONTOWN NJ 07724 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-08-29 |