MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-24 for FENIX CONTINENCE RESTORATION SYSTEM FS18 NA manufactured by Torax Medical, Inc..
[90105200]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced an infection and anal pain leading to fenix device explant. The fenix device was used as part of the surgical procedure. - uneventful surgical procedure and device implant on (b)(6) 2009. - patient began having infection and pain symptoms on (b)(6) 2017. - x-ray taken at 5-year study follow-up shows device in an annular state with no gaps between any beads. -uneventful device explant on (b)(6) 2017 due to infection and anal pain; the device was removed through the original incision. - the device was found in the correct position/geometry at the time of removal. - it was reported that the "the device was already opened when the procedure was made: the surgical thread was broken". -an anal abscess was observed, positioned at "3 o'clock". -patient is "doing well" as of (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2017-00123 |
| MDR Report Key | 6973303 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-24 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-04-29 |
| Date Mfgr Received | 2017-09-28 |
| Device Manufacturer Date | 2009-08-03 |
| Date Added to Maude | 2017-10-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TRESSA LAUER |
| Manufacturer Street | 4188 LEXINGTON AVENUE NORTH |
| Manufacturer City | SHOREVIEW MN 55126 |
| Manufacturer Country | US |
| Manufacturer Postal | 55126 |
| Manufacturer Phone | 6513618900 |
| Manufacturer G1 | TORAX MEDICAL, INC. |
| Manufacturer Street | 4188 LEXINGTON AVENUE NORTH |
| Manufacturer City | SHOREVIEW MN 55126 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FENIX CONTINENCE RESTORATION SYSTEM |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | PMH |
| Date Received | 2017-10-24 |
| Model Number | FS18 |
| Catalog Number | NA |
| Lot Number | 1944 |
| Device Expiration Date | 2011-08-03 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORAX MEDICAL, INC. |
| Manufacturer Address | 4188 LEXINGTON AVENUE N SHOREVIEW MN 55126 US 55126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2017-10-24 |