Brand Name | VLOCK XLG CLIP 6/CART 14/BOX |
Type of Device | CLIP, IMPLANTABLE |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
MDR Report Key | 8936253 |
MDR Text Key | 155706399 |
Report Number | 3011137372-2019-00267 |
Device Sequence Number | 1 |
Product Code |
FZP
|
Combination Product (y/n) | N |
PMA/PMN Number | K152082 |
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 |
08/08/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/27/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 71114V |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 09/13/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|