Brand Name | HUMELOCK REVERSED |
Type of Device | REVERSED SHOULDER PROTHESIS |
Manufacturer (Section D) |
FX SOLUTIONS |
1663 rue des majornas |
viriat, 01440 |
FR 01440 |
|
Manufacturer (Section G) |
FX SOLUTIONS |
1663 rue des majornas |
|
viriat, 01440 |
FR
01440
|
|
Manufacturer Contact |
emeric
obin
|
1663 rue des majornas |
viriat, 01440
|
FR
01440
|
|
MDR Report Key | 17433415 |
MDR Text Key | 320117751 |
Report Number | 3009532798-2023-00074 |
Device Sequence Number | 1 |
Product Code |
PHX
|
UDI-Device Identifier | 03701037300107 |
UDI-Public | 03701037300107 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/28/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 103-0806 |
Device Lot Number | T2398 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/27/2023 |
Initial Date FDA Received | 08/01/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|