Brand Name | VERSAJET II CONSOLE |
Type of Device | LAVAGE, JET |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
970 lake carillon dr. |
suite 110 |
st. petersburg FL 33716 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
970 lake carillon dr. |
suite 110 |
st. petersburg FL 33716 |
|
Manufacturer Contact |
terry
mcmahon
|
970 lake carillon dr. |
suite 110 |
st. petersburg, FL 33716
|
7273993785
|
|
MDR Report Key | 4517375 |
MDR Text Key | 5950413 |
Report Number | 3006760724-2015-00011 |
Device Sequence Number | 1 |
Product Code |
FQH
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K110958 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/11/2015 |
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 |
Physician
|
Device Model Number | 66800039 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/07/2015 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/21/2015 |
Initial Date FDA Received | 02/13/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/11/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|