Brand Name | VERSAJET II EXACT 45DEG X 14MM |
Type of Device | LAVAGE, JET |
Manufacturer (Section D) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
hull HU3 2 BN |
UK HU3 2BN |
|
Manufacturer (Section G) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
|
hull HU3 2 BN |
UK
HU3 2BN
|
|
Manufacturer Contact |
sarah
freestone
|
101 hessle road |
hull HU3 2-BN
|
UK
HU3 2BN
|
4407940038
|
|
MDR Report Key | 9940406 |
MDR Text Key | 187758015 |
Report Number | 8043484-2020-00274 |
Device Sequence Number | 1 |
Product Code |
FQH
|
Combination Product (y/n) | N |
Reporter Country Code | MY |
PMA/PMN Number | K110958 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/17/2020 |
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 Catalogue Number | 66800041 |
Device Lot Number | 50822790 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/19/2020 |
Initial Date FDA Received | 04/08/2020 |
Supplement Dates Manufacturer Received | 12/16/2020
|
Supplement Dates FDA Received | 12/17/2020
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |