MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-07 for ONE TRAY manufactured by Innovative Sterilization Technologies Llc.
| Report Number | 8678224 |
| MDR Report Key | 8678224 |
| Date Received | 2019-06-07 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-02-13 |
| Report Date | 2019-06-04 |
| Date Reported to FDA | 2019-06-04 |
| Date Reported to Mfgr | 2019-06-07 |
| Date Added to Maude | 2019-06-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE TRAY |
| Generic Name | STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES |
| Product Code | KCT |
| Date Received | 2019-06-07 |
| Returned To Mfg | 2019-03-07 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOVATIVE STERILIZATION TECHNOLOGIES LLC |
| Manufacturer Address | 7625 PARAGON RD STE A DAYTON OH 45459 US 45459 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-07 |