Brand Name | FENIX CONTINENCE RESTRORATION SYSTEM |
Type of Device | IMPLANTED FECAL INCONTINENCE DEVICE |
Manufacturer (Section D) |
TORAX MEDICAL, INC. |
4188 lexington avenue n |
shoreview MN 55126 |
|
Manufacturer (Section G) |
TORAX MEDICAL, INC. |
4188 lexington avenue north |
|
shoreview MN 55126 |
|
Manufacturer Contact |
daniel
hoseck
|
4188 lexington avenue north |
shoreview, MN 55126
|
6513618900
|
|
MDR Report Key | 6091472 |
MDR Text Key | 59552282 |
Report Number | 3008766073-2016-00086 |
Device Sequence Number | 1 |
Product Code |
PMH
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | H130006 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/13/2016 |
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 |
Physician
|
Device Expiration Date | 04/24/2018 |
Device Model Number | FS16 |
Device Lot Number | 6115 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/13/2016 |
Initial Date FDA Received | 11/09/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/24/2014 |
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;
Other;
|
Patient Age | 64 YR |