Brand Name | RENASYS GO NPWT DEVICE |
Type of Device | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
Manufacturer (Section D) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
hull HU3 2 BN |
UK HU3 2BN |
|
Manufacturer (Section G) |
SMITH & NEPHEW ENDOSCOPY |
76 s. meridian avenue |
|
oklahoma city OK 73107 |
|
Manufacturer Contact |
markus
poettker
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
|
MDR Report Key | 6577700 |
MDR Text Key | 75504081 |
Report Number | 8043484-2017-00148 |
Device Sequence Number | 1 |
Product Code |
OMP
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K083375 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
07/24/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/19/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 66800164 |
Device Catalogue Number | 66800164 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/21/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |