Brand Name | HAMILTON |
Type of Device | HAMILTON-G5 |
Manufacturer (Section D) |
HAMILTON MEDICAL AG |
via crusch 8 |
bonaduz, 7402 |
SZ 7402 |
|
MDR Report Key | 11211342 |
MDR Text Key | 228161538 |
Report Number | 0002937708-2021-00006 |
Device Sequence Number | 1 |
Product Code |
CBK
|
UDI-Device Identifier | 07630002800013 |
UDI-Public | 07630002800013 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/21/2021,08/15/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | 159001 |
Device Catalogue Number | 159001 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/21/2021 |
Distributor Facility Aware Date | 01/11/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 01/21/2021 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 01/21/2021 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 08/15/2022
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|