Brand Name | CCU, ARTHREX SYNERGY UHD4 |
Type of Device | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
Manufacturer (Section D) |
ARTHREX, INC. |
1370 creekside boulevard |
naples FL 34108 1945 |
|
MDR Report Key | 11046592 |
MDR Text Key | 222681749 |
Report Number | 1220246-2020-02420 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
UDI-Device Identifier | 00888867197022 |
UDI-Public | 00888867197022 |
Combination Product (y/n) | N |
PMA/PMN Number | K153218 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup |
Report Date |
08/10/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | CCU, ARTHREX SYNERGY UHD4 |
Device Catalogue Number | AR-3200-0021 |
Device Lot Number | 10216260 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
11/30/2020 |
Initial Date FDA Received | 12/21/2020 |
Supplement Dates Manufacturer Received | 11/30/2020
|
Supplement Dates FDA Received | 08/10/2021
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|