Brand Name | HUMELOCK II |
Type of Device | SHOULDER PROTHESIS |
Manufacturer (Section D) |
FX SOLUTIONS |
1663 rue de majornas |
viriat, 01440 |
FR 01440 |
|
Manufacturer (Section G) |
FX SOLUTIONS |
1663 rue de majornas |
|
viriat, 01440 |
FR
01440
|
|
Manufacturer Contact |
cédric
joly
|
1663 rue de majornas |
viriat, 01440
|
FR
01440
|
|
MDR Report Key | 10300655 |
MDR Text Key | 199640473 |
Report Number | 3009532798-2020-00302 |
Device Sequence Number | 1 |
Product Code |
HSD
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K111097 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/21/2020 |
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 Expiration Date | 03/01/2023 |
Device Model Number | 106-4617 |
Device Lot Number | L1818 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/13/2020 |
Initial Date FDA Received | 07/21/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/13/2018 |
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;
|