Brand Name | ESOP HA |
Type of Device | DIAPHYSIS STEM DIA11 |
Manufacturer (Section D) |
FH INDUSTRIE |
6 rue nobel |
quimper, france 29000 |
FR 29000 |
|
Manufacturer (Section G) |
FH INDUSTRIE |
6 rue nobel |
|
quimper, france 29000 |
FR
29000
|
|
Manufacturer Contact |
ruillier
|
3 rue de la forêt |
heimsbrunn, france 68990
|
|
MDR Report Key | 6581089 |
MDR Text Key | 177369199 |
Report Number | 3003898228-2016-00013 |
Device Sequence Number | 1 |
Product Code |
MEH
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K021108 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
05/18/2017 |
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 |
Other Health Care Professional
|
Device Catalogue Number | 233633 201119 |
Device Lot Number | F01504 RG01857 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/12/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/13/2016 |
Initial Date FDA Received | 05/22/2017 |
Supplement Dates Manufacturer Received | 12/13/2016
|
Supplement Dates FDA Received | 05/22/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 60 YR |