MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-12-17 for TROJAN SUPRA * 22600-0903-20 manufactured by Carter-wallace Inc.
[21399653]
Rptr had 2 pts report increased breakage with trojan supra microsheer polyurethane ultra thin condoms with spermicidal lubricant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023649 |
| MDR Report Key | 367739 |
| Date Received | 2001-12-17 |
| Date of Report | 2001-12-17 |
| Date Added to Maude | 2001-12-27 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | TROJAN SUPRA |
| Generic Name | POLYURETHANE CONDOMS |
| Product Code | LTZ |
| Date Received | 2001-12-17 |
| Model Number | * |
| Catalog Number | 22600-0903-20 |
| Lot Number | * |
| ID Number | NDC 22600-0903-20 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 356859 |
| Manufacturer | CARTER-WALLACE INC |
| Manufacturer Address | * NEW YORK NY 10105 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-12-17 |