Brand Name | RENASYS GO |
Type of Device | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
Manufacturer (Section D) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
hull east riding of yorkshire HU3 2 BN |
UK HU3 2BN |
|
Manufacturer (Section G) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
|
hull east riding of yorkshire HU3 2 BN |
UK
HU3 2BN
|
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 13078531 |
MDR Text Key | 284634019 |
Report Number | 8043484-2021-02052 |
Device Sequence Number | 1 |
Product Code |
OMP
|
UDI-Device Identifier | 05000223491000 |
UDI-Public | 05000223491000 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K152163 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/26/2022 |
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 Model Number | 66021496 |
Device Catalogue Number | 66021496 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/09/2021 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/03/2021 |
Initial Date FDA Received | 12/23/2021 |
Supplement Dates Manufacturer Received | 01/26/2022
|
Supplement Dates FDA Received | 01/26/2022
|
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 |
Unknown
|
Patient Sequence Number | 1 |