MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-06-25 for TROJAN CONDOMS MAGNUM RIBBED LUBRICATED manufactured by Church & Dwight Co., Inc..
[22038738]
Consumer reports condom breakage with unconfirmed transmission of a sexually transmitted disease.
Patient Sequence No: 1, Text Type: D, B5
[22295682]
Consumer returned condoms with different lot code numbers tt3295 and tt3350. The device manufacture date for lot code number tt3295 is (b)(6) 2013 and the manufacture date for lot code number tt3350 is (b)(6) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2280705-2015-00027 |
| MDR Report Key | 4867820 |
| Report Source | 04 |
| Date Received | 2015-06-25 |
| Date of Report | 2015-06-25 |
| Date Mfgr Received | 2015-05-27 |
| Date Added to Maude | 2015-06-25 |
| 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 CONDOMS MAGNUM RIBBED LUBRICATED |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2015-06-25 |
| 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. Life Threatening | 2015-06-25 |