Brand Name | HI-TORQUE CONNECT 250T,30G,300 |
Type of Device | HI-TORQUE CONNECT 250T,30G,300 |
Manufacturer (Section D) |
BRIVANT LTD. T/A LAKE REGION MEDICAL |
parkmore west business park |
galway, ei |
EI |
|
MDR Report Key | 9828845 |
MDR Text Key | 192038850 |
Report Number | 3006010712-2020-00003 |
Device Sequence Number | 1 |
Product Code |
DQX
|
Combination Product (y/n) | N |
PMA/PMN Number | K112381 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
02/21/2020 |
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 Model Number | 901022-09 |
Device Catalogue Number | 1012595 |
Device Lot Number | 4833577 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/21/2020
|
Initial Date FDA Received | 03/13/2020 |
Supplement Dates Manufacturer Received | 02/21/2020
|
Supplement Dates FDA Received | 04/14/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|