MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-02 for TROJAN RIBBED CONDOM WITH NONOXYNOL 9 manufactured by Carter-wallace, Inc..
[27029]
Pt believes he is reacting to the spermicide. Pt used 1 condom 3/20 pm and 3/21 am. Pt reports very severe burning at the urethral opening on urination, redness and induration of approx 2-3 ml around tip. No blood or discharge seen. Pt indicated a similar but much less severe response occurred with the same product about 1 year ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009002 |
| MDR Report Key | 32516 |
| Date Received | 1996-05-02 |
| Date of Report | 1996-03-22 |
| Date of Event | 1996-03-20 |
| Date Added to Maude | 1996-05-07 |
| 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 RIBBED CONDOM WITH NONOXYNOL 9 |
| Generic Name | CONDOM WITH NONOXYNOL 9 |
| Product Code | LTZ |
| Date Received | 1996-05-02 |
| Lot Number | 29941 |
| Device Expiration Date | 1998-10-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33796 |
| Manufacturer | CARTER-WALLACE, INC. |
| Manufacturer Address | CRANBURY NJ 08512 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-05-02 |