MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-07-21 for STERIZONE VP4 STERILIZER 44000-R manufactured by Tso3 Inc..
[80749808]
Investigation on the device was conducted on site by service technician. All test verifications were performed and the unit met manufacturer specifications. There is no evidence that this event was related to a device defect or malfunction. The issue is associated with the use of the device in terms of non-conforming to the device's instructions and information provided by the device manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[80749809]
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 | 3004148947-2017-00002 |
| MDR Report Key | 6734033 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-06-22 |
| Device Manufacturer Date | 2017-04-20 |
| Date Added to Maude | 2017-07-21 |
| 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 | MR. ALEXANDRE JOKIC |
| Manufacturer Street | 2505 DALTON AVENUE |
| Manufacturer City | QUEBEC, QUEBEC G1P 3S5 |
| Manufacturer Country | CA |
| Manufacturer Postal | G1P 3S5 |
| Manufacturer G1 | TSO3 INC. |
| Manufacturer Street | 2505 DALTON AVENUE |
| Manufacturer City | QUEBEC, QUEBEC G1P 3S5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | G1P 3S5 |
| 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 Eval'ed by Mfgr | Y |
| 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 |