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 |
jessica
ahlborn
|
4188 lexington avenue north |
shoreview, MN 55126
|
6513618900
|
|
MDR Report Key | 6802365 |
MDR Text Key | 82977162 |
Report Number | 3008766073-2017-00095 |
Device Sequence Number | 1 |
Product Code |
PMH
|
UDI-Device Identifier | 00855106005493 |
UDI-Public | 00855106005493 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | H130006 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
08/31/2017 |
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 | 03/16/2020 |
Device Model Number | FXS16 |
Device Lot Number | 10522 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/28/2017 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/21/2017 |
Initial Date FDA Received | 08/17/2017 |
Supplement Dates Manufacturer Received | 08/31/2017
|
Supplement Dates FDA Received | 09/20/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/16/2016 |
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 | 76 YR |