MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-16 for TROJAN LATEX CONDOMS UNSPECIFIED manufactured by Church & Dwight Co., Inc..
[177582849]
This report and the information submitted under this report do not constitute an admission that the device or church & dwight co. , inc. Or any of its employees caused or contributed to the event described herein or that the event as reported to church & dwight actually occurred. Also, please note that this report is being submitted late due to technical issues with the esg help desk establishing my production account. All emails with the esg help desk regarding this issue have been saved and can be provided if necessary.
Patient Sequence No: 1, Text Type: N, H10
[177582850]
The consumer stated that he used these condoms all of his life and they break every time. The consumer also stated that he had to get a std test after this happened. He also alleges that a friend of his is currently undergoing a pep treatment because the condom broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2280705-2020-00003 |
| MDR Report Key | 9598105 |
| Report Source | CONSUMER |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2019-12-30 |
| Date Added to Maude | 2020-01-16 |
| 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 LATEX CONDOMS UNSPECIFIED |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2020-01-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2020-01-16 |