Brand Name | UNKNOWN PICO |
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 MEDICAL LTD. |
101 hessle road |
|
hull HU3 2 BN |
UK
HU3 2BN
|
|
Manufacturer Contact |
claudia
de santis
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
0628320660
|
|
MDR Report Key | 6416879 |
MDR Text Key | 70319841 |
Report Number | 8043484-2017-00092 |
Device Sequence Number | 1 |
Product Code |
OMP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112127 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/09/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Lot Number | 1546 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/08/2017 |
Initial Date FDA Received | 03/20/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/09/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|