Brand Name | TALUX PYRAMID C6 27CM RIGHT |
Type of Device | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT |
Manufacturer (Section D) |
OSSUR H/F |
grjothals 5 |
reykjavik, 110 |
IC 110 |
|
Manufacturer (Section G) |
OSSUR H/F |
grjothals 5 |
|
reykjavik, 110 |
IC
110
|
|
Manufacturer Contact |
karen
montes
|
27051 towne centre |
foothill ranch, CA 92610
|
9492757557
|
|
MDR Report Key | 6509127 |
MDR Text Key | 73333037 |
Report Number | 3003764610-2017-00002 |
Device Sequence Number | 1 |
Product Code |
ISH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
04/20/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/20/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | TLP0627R |
Device Catalogue Number | TLP0627R |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/06/2017 |
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 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 60 YR |
Patient Weight | 109 |
|
|