MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-08-19 for TROJAN ULTRA THIN LUBRICATED CONDOMS, 12 CT manufactured by Church & Dwight Co., Inc..
| Report Number | 2280705-2019-00015 |
| MDR Report Key | 8906107 |
| Report Source | CONSUMER |
| Date Received | 2019-08-19 |
| Date of Report | 2019-07-08 |
| Date Mfgr Received | 2019-06-09 |
| Date Added to Maude | 2019-08-19 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. STACEY HARSHAW |
| Manufacturer Street | 469 NORTH HARRISON STREET |
| Manufacturer City | PRINCETON NJ 08543 |
| Manufacturer Country | US |
| Manufacturer Postal | 08543 |
| Manufacturer Phone | 6098067868 |
| Manufacturer G1 | CHURCH & DWIGHT CO., INC. |
| Manufacturer Street | 1851 TOUCHSTONE DRIVE |
| Manufacturer City | SOUTH CHESTERFIELD VA 23834 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 23834 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TROJAN ULTRA THIN LUBRICATED CONDOMS, 12 CT |
| Generic Name | CONDOM, PRODUCT CODE: HIS |
| Product Code | HIS |
| Date Received | 2019-08-19 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-08-19 |