Brand Name | HYST. FLUID MGMT SYSTEM CONTROL UNIT |
Type of Device | HYST. FLUID MGMT SYSTEM CONTROL UNIT |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
76 s. meridian ave. |
oklahoma city OK 73107 651 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
76 s. meridian ave. |
|
oklahoma city OK 7310 7-65 |
|
Manufacturer Contact |
brenda
driscoll
|
150 minuteman road |
andover, MA 01810
|
9787491462
|
|
MDR Report Key | 4107722 |
MDR Text Key | 20857641 |
Report Number | 1643264-2014-00025 |
Device Sequence Number | 1 |
Product Code |
HIG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K031616 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/25/2014 |
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 |
Health Professional
|
Device Model Number | 7210164 |
Device Catalogue Number | 7210164 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/25/2014 |
Initial Date FDA Received | 09/22/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|