Brand Name | ARROW |
Type of Device | ARROW GLENOSPHERE COCR D42 |
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 foret |
heimsbrunn, 68990
|
FR
68990
|
|
MDR Report Key | 12342859 |
MDR Text Key | 267284605 |
Report Number | 3003898228-2021-00005 |
Device Sequence Number | 1 |
Product Code |
KWS
|
UDI-Device Identifier | 03661489651526 |
UDI-Public | 03661489651526 |
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 |
company representative |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Replace |
Type of Report
| Initial |
Report Date |
08/21/2021 |
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 |
No Information
|
Device Expiration Date | 06/23/2020 |
Device Model Number | 265152 |
Device Lot Number | E04703 |
Initial Date Manufacturer Received |
07/21/2021 |
Initial Date FDA Received | 08/19/2021 |
Was Device Evaluated by Manufacturer? |
No
|
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) |
Required Intervention;
|
|
|