Brand Name | BREG POST-OP SHOE |
Type of Device | POST-OP SHOE |
Manufacturer (Section D) |
BREG, INC. |
2885 loker avenue east |
carlsbad CA 92010 |
|
Manufacturer (Section G) |
BREG, INC. |
2885 loker avenue east |
|
carlsbad CA 92010 |
|
Manufacturer Contact |
carol
emerson
|
2885 loker avenue east |
carlsbad, CA 92010
|
7607955823
|
|
MDR Report Key | 5066105 |
MDR Text Key | 26006676 |
Report Number | 2028253-2015-00005 |
Device Sequence Number | 1 |
Product Code |
IQI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Report Date |
09/08/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/09/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 08/11/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|