Brand Name | LEICA RM2235 |
Type of Device | RM2235 |
Manufacturer (Section D) |
LEICA BIOSYSTEMS NUSSLOCH GMBH |
heidelbergerstrasse 17-19 |
nussloch, 69226 |
GM 69226 |
|
Manufacturer (Section G) |
LEICA MICROSYSTEMS LTD. SHANGHAI |
building 1, 258 jinzang road |
|
shanghai,pudong, 20120 6 |
CH
201206
|
|
Manufacturer Contact |
robert
gropp
|
heidelbergerstr. 17-19 |
nussloch, 69226
|
GM
69226
|
|
MDR Report Key | 14157709 |
MDR Text Key | 289603922 |
Report Number | 8010478-2022-00002 |
Device Sequence Number | 1 |
Product Code |
IDO
|
UDI-Device Identifier | 04049188002242 |
UDI-Public | (01)04049188002242 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
10/30/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/20/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 1492235EUUL |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 04/20/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/07/2012 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Sex | Male |
|
|