Brand Name | AMSCO 600 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
|
4403927453
|
|
MDR Report Key | 12637423 |
MDR Text Key | 281676563 |
Report Number | 3005899764-2021-00053 |
Device Sequence Number | 1 |
Product Code |
FLE
|
UDI-Device Identifier | 00724995179434 |
UDI-Public | 00724995179434 |
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 |
10/14/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/14/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | AMSCO 600 Steam Sterilizer |
Device Catalogue Number | EF1201142 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/16/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/28/2021 |
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 |
|
|