MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-21 for STERIZONE VP4 STERILIZER 44000-R manufactured by Tso3 Inc..
[80749974]
It was reported that a user of the device, upon reloading a cart while getting ready to load the machine, got a burning sensation coming from under the gloves, removed them and washed her hands. There was no report of a medical evaluation or medical treatment associated with the alleged event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011762828-2017-00002 |
| MDR Report Key | 6734026 |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-06-21 |
| Date Facility Aware | 2017-06-22 |
| Report Date | 2017-07-21 |
| Date Reported to FDA | 2017-07-21 |
| Date Reported to Mfgr | 2017-07-21 |
| Date Added to Maude | 2017-07-21 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERIZONE VP4 STERILIZER |
| Generic Name | TWO OR MORE STERILANT STERILIZER |
| Product Code | PJJ |
| Date Received | 2017-07-21 |
| Model Number | 44000-R |
| Catalog Number | 44000-R |
| Lot Number | NA |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TSO3 INC. |
| Manufacturer Address | 2505 DALTON AVENUE QUEBEC, QUEBEC G1P 3S5 CA G1P 3S5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-21 |