MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-04-08 for BEYOND SEVEN manufactured by Okamoto Rubber Products Co., Ltd..
[5719828]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13159729]
The individual mentioned he has no product left on hand and he does not have lot identification information either.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610410-2015-00001 |
| MDR Report Key | 4707526 |
| Report Source | 04 |
| Date Received | 2015-04-08 |
| Date Mfgr Received | 2015-03-10 |
| Date Added to Maude | 2015-05-19 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 3130 WEST MONROE STREET |
| Manufacturer City | SANDUSKY OH 44870 |
| Manufacturer Country | US |
| Manufacturer Postal | 44870 |
| Manufacturer Phone | 4196261633 |
| Manufacturer G1 | OKAMOTO RUBBER PRODUCTS CO., LTD. |
| Manufacturer Street | 60/50 NAVANAKORN IND. ESTATE 2, PHAHOLYOTHIN RD. |
| Manufacturer City | PATHUMTHANI 12120 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 12120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEYOND SEVEN |
| Generic Name | CONDOM (RUBBER) CONTRACEPTIVE |
| Product Code | HIS |
| Date Received | 2015-04-08 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OKAMOTO RUBBER PRODUCTS CO., LTD. |
| Manufacturer Address | TH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-08 |