Brand Name | 4580 FMS DUO+ PUMP/SHAVER COMBO -NS |
Type of Device | DISTENSION UNIT, FLUID, ARTHROSCOPIC |
Manufacturer (Section D) |
DEPUY MITEK LLC US |
325 paramount drive |
raynham MA 02767 |
|
Manufacturer (Section G) |
DEPUY MITEK LLC US |
325 paramount drive |
|
raynham MA 02767 |
|
Manufacturer Contact |
jennifer
lawrence
|
325 paramount drive |
raynham, MA 02767
|
5088808100
|
|
MDR Report Key | 8009196 |
MDR Text Key | 125145336 |
Report Number | 1221934-2018-50746 |
Device Sequence Number | 1 |
Product Code |
HRX
|
UDI-Device Identifier | 10886705020607 |
UDI-Public | 10886705020607 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K954465 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/30/2015 |
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 |
Health Professional
|
Device Catalogue Number | 284580 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/30/2015 |
Initial Date FDA Received | 10/26/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |