Brand Name | VERSAJET EXACT ASSY, 45 DEGREE X 8MM |
Type of Device | LAVAGE, JET |
Manufacturer (Section D) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
hull east riding of yorkshire HU3 2 BN |
UK HU3 2BN |
|
MDR Report Key | 10166800 |
MDR Text Key | 195538467 |
Report Number | 8043484-2020-00821 |
Device Sequence Number | 1 |
Product Code |
FQH
|
UDI-Device Identifier | 04582111153562 |
UDI-Public | 4582111153562 |
Combination Product (y/n) | N |
PMA/PMN Number | K110958 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
03/17/2021 |
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 |
Health Professional
|
Device Catalogue Number | 66800042 |
Device Lot Number | 50824282 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/20/2020
|
Initial Date FDA Received | 06/18/2020 |
Supplement Dates Manufacturer Received | 03/17/2021
|
Supplement Dates FDA Received | 03/17/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|