MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-26 for TROJAN ENZ WITH ARMOR SPERMICIDAL LUBRICANT CONDOMS manufactured by Church & Dwight Co., Ltd..
[125630629]
My boyfriend and i have used the trojan enz brand condoms for a long time. Recently they released an enz brand with spermicidal lubricant (armor spermicidal lubricant). Within 12 hours of having sex the first time we used these, i developed extremely bad pelvic pain and later symptoms of a uti. I went to the dr and sure enough, i had a uti. This was an especially bad case with terrible pelvic cramping and tenderness in the pelvis and bladder. My dr informed me that some women have this reaction to spermicidal lubricants. Is the product over-the-counter? Yes. Did the problem stop after the person reduced the dose or stopped taking or using the product again? No. Quantity: 1 application; how was it taken or used: topical; date the person first started taking or using the product: (b)(6) 2018, date the person stopped taking or using the product: (b)(6) 2018. Reason for use: pregnancy prevention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080897 |
| MDR Report Key | 8014573 |
| Date Received | 2018-10-26 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-10-19 |
| Date Added to Maude | 2018-10-29 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TROJAN ENZ WITH ARMOR SPERMICIDAL LUBRICANT CONDOMS |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2018-10-26 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHURCH & DWIGHT CO., LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-10-26 |