MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for ONE TRAY PROCESSING KIT TAMPER EVIDENT LOCKS WITH INDICATOR DOTS OTK-210 manufactured by Innovative Sterilization Technologies Llc.
[144252955]
Innovative sterilization technologies, one tray processing kit, one of two of the "tamper evident locks with indicator dots", did not transition to "black" following processing. The internal "integrator" had fully transitioned, and the "biological" test was negative. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086380 |
| MDR Report Key | 8582401 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-05-01 |
| Date Added to Maude | 2019-05-06 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ONE TRAY PROCESSING KIT TAMPER EVIDENT LOCKS WITH INDICATOR DOTS |
| Generic Name | WRAP CONTAINERS, TRAYS, CASSETTES AND OTHER ACCESSORIES |
| Product Code | KCT |
| Date Received | 2019-05-03 |
| Model Number | OTK-210 |
| Catalog Number | OTK-210 |
| Lot Number | K03180884 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOVATIVE STERILIZATION TECHNOLOGIES LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-03 |