Brand Name | HNG |
Type of Device | COCR FEMORAL HEAD D28 12/14 D28 M (+0) USA |
Manufacturer (Section D) |
FH INDUSTRIE |
6 rue nobel |
quimper, 29000 |
FR 29000 |
|
Manufacturer (Section G) |
FH INDUSTRIE |
6 rue nobel |
|
quimper, 29000 |
FR
29000
|
|
Manufacturer Contact |
el yazid
aribi
|
6 rue nobel |
quimper, 29000
|
FR
29000
|
|
MDR Report Key | 17948829 |
MDR Text Key | 325825547 |
Report Number | 3003898228-2023-00012 |
Device Sequence Number | 1 |
Product Code |
LPH
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K021109 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
10/10/2023 |
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 |
Lay User/Patient
|
Device Expiration Date | 03/13/2021 |
Device Catalogue Number | 268156 |
Device Lot Number | RG01761 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/09/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/27/2020
|
Initial Date FDA Received | 10/17/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/01/2016 |
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 |