Brand Name | V-PRO MAX 2 STERILIZER |
Type of Device | STERILIZER |
Manufacturer (Section D) |
STERIS MEXICO, S. DE R.L. DE C.V. |
avenida avante 790 |
parque industrial guadalupe |
guadalupe, 67190 |
MX 67190 |
|
Manufacturer (Section G) |
STERIS MEXICO, S. DE R.L. DE C.V. |
avenida avante 790 |
parque industrial guadalupe |
guadalupe, 67190 |
MX
67190
|
|
Manufacturer Contact |
daniel
davy
|
5960 heisley road |
mentor, OH 44060
|
|
MDR Report Key | 18506643 |
MDR Text Key | 333486733 |
Report Number | 3005899764-2024-00004 |
Device Sequence Number | 1 |
Product Code |
MLR
|
UDI-Device Identifier | 00724995158354 |
UDI-Public | 00724995158354 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/12/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/12/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/14/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/06/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|