Brand Name | HEAVY DUTY TRAPEZE |
Type of Device | PATIENT HELPER |
Manufacturer (Section D) |
MIZUHO ORTHOPEDIC SYSTEMS, INC. |
30031 ahern avenue |
union city CA 94587 1234 |
|
Manufacturer (Section G) |
MIZUHO ORTHOPEDIC SYSTEMS, INC. |
30031 ahern avenue |
|
union city CA 94587 1234 |
|
Manufacturer Contact |
anne
leblanc
|
30031 ahern avenue |
union city, CA 94587-1234
|
5104291500
|
|
MDR Report Key | 5524130 |
MDR Text Key | 41460782 |
Report Number | 2921578-2016-00007 |
Device Sequence Number | 1 |
Product Code |
HST
|
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,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/22/2016 |
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 |
Lay User/Patient
|
Device Model Number | 3095 |
Device Catalogue Number | 3095 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/16/2016 |
Initial Date FDA Received | 03/24/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 07/22/2016
|
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 |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Weight | 91 |
|
|