Brand Name | ARROW SHOULDER |
Type of Device | ARROW GLENOSPHERE |
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 fôret |
heimsbrunn, france 68990
|
|
MDR Report Key | 6581091 |
MDR Text Key | 177369090 |
Report Number | 3003898228-2017-00001 |
Device Sequence Number | 1 |
Product Code |
KWS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112193 |
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 |
04/19/2017 |
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 Expiration Date | 04/14/2018 |
Device Catalogue Number | 265152 |
Device Lot Number | D00039 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/17/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/17/2017 |
Initial Date FDA Received | 05/22/2017 |
Supplement Dates Manufacturer Received | 01/17/2017
|
Supplement Dates FDA Received | 05/22/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/14/2013 |
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 |