Brand Name | RENASYS GO |
Type of Device | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
970 lake carillon dr |
st petersburg FL 33716 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
970 lake carillon dr |
|
st petersburg FL 33716 |
|
Manufacturer Contact |
claudia
odoy
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
0628320660
|
|
MDR Report Key | 5485674 |
MDR Text Key | 40057593 |
Report Number | 3006760724-2016-00027 |
Device Sequence Number | 1 |
Product Code |
OMP
|
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | K083375 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/16/2016 |
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 | 66800161 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/19/2016 |
Initial Date FDA Received | 03/08/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 08/08/2016
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|