MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-16 for 121716 manufactured by Synergy Health North America.
[62971705]
Even though there were no reported adverse events, the medwatch report is being filed in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[62971706]
There appeared to be a blue substance and red spots on the stainless basin that is used for solutions in the or.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001527607-2016-00001 |
| MDR Report Key | 6182935 |
| Date Received | 2016-12-16 |
| Date of Report | 2016-12-16 |
| Date of Event | 2016-11-17 |
| Date Mfgr Received | 2016-11-16 |
| Device Manufacturer Date | 2016-11-16 |
| Date Added to Maude | 2016-12-16 |
| 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. ZILLERY FORTNER |
| Manufacturer Street | 7086 INDUSTRIAL ROW ROAD |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer G1 | SYNERGY HEALTH NORTH AMERICA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | BASIN |
| Product Code | FNY |
| Date Received | 2016-12-16 |
| Model Number | 121716 |
| Catalog Number | 121716 |
| Lot Number | 538562001 |
| ID Number | NI |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGY HEALTH NORTH AMERICA |
| Manufacturer Address | 7086 INDUSTRIAL ROW ROAD MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-16 |