Brand Name | FENIX CONTINENCE RESTORATION 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 |
tressa
lauer
|
4188 lexington avenue north |
shoreview, MN 55126
|
6513618900
|
|
MDR Report Key | 6973303 |
MDR Text Key | 90105200 |
Report Number | 3008766073-2017-00123 |
Device Sequence Number | 1 |
Product Code |
PMH
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
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 |
09/28/2017 |
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 | 08/03/2011 |
Device Model Number | FS18 |
Device Lot Number | 1944 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/28/2017
|
Initial Date FDA Received | 10/24/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/03/2009 |
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;
Disability;
|
Patient Age | 48 YR |
Patient Weight | 93 |