Brand Name | ARROW |
Type of Device | ARROW GLENOSPHERE Ø39 |
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 |
cécilia
hernoux
|
3 rue de la forêt |
heimsbrunn, 68990
|
FR
68990
|
|
MDR Report Key | 9816993 |
MDR Text Key | 200627421 |
Report Number | 3003898228-2020-00003 |
Device Sequence Number | 1 |
Product Code |
KWT
|
Combination Product (y/n) | N |
Reporter Country Code | ET |
PMA/PMN Number | K112193 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/12/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/11/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 260567 |
Device Lot Number | J01031 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/12/2020 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 02/12/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/24/2018 |
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) |
Other;
|
|
|