Brand Name | OMNI HIP SYSTEM |
Type of Device | PROSTHESIS, HIP, HEMI |
Manufacturer (Section D) |
OMNILIFE SCIENCE, INC. |
480 paramount drive |
raynham, ma |
|
Manufacturer (Section G) |
OMNILIFE SCIENCE, INC. |
480 paramount drive |
|
raynham, ma |
|
Manufacturer Contact |
christina
rovaldi
|
480 paramount drive |
raynham, ma
|
4486664
|
|
MDR Report Key | 10302585 |
MDR Text Key | 199905590 |
Report Number | 1226188-2020-00122 |
Device Sequence Number | 1 |
Product Code |
KWY
|
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 |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/21/2020 |
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
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/01/2020
|
Initial Date FDA Received | 07/21/2020 |
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 56 YR |
|
|