MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-01-30 for TROJAN CONDOM UNKNOWN manufactured by Church & Dwight Co., Inc..
[5183059]
Consumer reports condom breakage with unconfirmed transmission of a sexually transmitted disease.
Patient Sequence No: 1, Text Type: D, B5
[12800214]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2280705-2015-00014 |
| MDR Report Key | 4469160 |
| Report Source | 04 |
| Date Received | 2015-01-30 |
| Date of Report | 2015-01-30 |
| Date Mfgr Received | 2015-01-05 |
| Date Added to Maude | 2015-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. LYNN MOODY |
| Manufacturer Street | 469 NORTH HARRISON STREET |
| Manufacturer City | PRINCETON NJ 085435297 |
| Manufacturer Country | US |
| Manufacturer Postal | 085435297 |
| Manufacturer Phone | 6098061431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TROJAN CONDOM UNKNOWN |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2015-01-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHURCH & DWIGHT CO., INC. |
| Manufacturer Address | 500 CHARLES EWING BOULEVARD EWING NJ 08628 US 08628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-30 |