Brand Name | ORGANOX METRA |
Type of Device | NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR |
Manufacturer (Section D) |
ORGANOX LIMITED |
oxford science park, magdalen |
centre, robert robinson avenue |
oxford, oxfordshire gb OX4 4 GA |
UK OX4 4GA |
|
Manufacturer (Section G) |
RAUMEDIC - MUENCHBERG |
hermann-staudinger strasse 2 |
|
helmbrechts, bavaria 95233 |
GM
95233
|
|
Manufacturer Contact |
ruth
colwill
|
oxford science park, magdalen |
centre, robert robinson avenue |
oxford, oxfordshire, gb OX4 4-GA
|
UK
OX4 4GA
|
|
MDR Report Key | 18946471 |
MDR Text Key | 338769321 |
Report Number | 3011560054-2024-00004 |
Device Sequence Number | 1 |
Product Code |
QQK
|
UDI-Device Identifier | 05060462240029 |
UDI-Public | 5060462240029 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P200035 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/29/2024 |
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 Operator |
Health Professional
|
Device Model Number | D0146 |
Device Catalogue Number | D0146 |
Device Lot Number | 11152743 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Initial Date Manufacturer Received |
02/22/2024
|
Initial Date FDA Received | 03/20/2024 |
Supplement Dates Manufacturer Received | 02/22/2024
|
Supplement Dates FDA Received | 04/29/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/26/2023 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|