MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-08 for BEYOND SEVEN 28373 71000 manufactured by Okamoto Rubber Products Co Ltd.,.
[21546688]
Customer reported that the condom was broken and resulted in his girlfriend pregnant. Mfr#: 9610410-2015-00001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431332-2015-00001 |
| MDR Report Key | 4777195 |
| Date Received | 2015-04-08 |
| Date of Report | 2015-04-08 |
| Date of Event | 2015-01-01 |
| Date Facility Aware | 2015-03-10 |
| Date Reported to Mfgr | 2015-03-10 |
| Date Added to Maude | 2015-05-19 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 0 |
| Manufacturer Street | 18 KING ST. |
| Manufacturer City | STRATFORD CT 06615 |
| Manufacturer Country | US |
| Manufacturer Postal | 06615 |
| Manufacturer G1 | OKAMOTO U.S.A., INC. |
| Manufacturer Street | 18 KING ST. |
| Manufacturer City | STRATFORD CT 06615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06615 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEYOND SEVEN |
| Generic Name | CONDOM (RUBBER) CONTRACEPTIVE |
| Product Code | HIS |
| Date Received | 2015-04-08 |
| Model Number | 28373 71000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OKAMOTO RUBBER PRODUCTS CO LTD., |
| Manufacturer Address | TH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-08 |