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 2018-02-23 for FENIX CONTINENCE RESTORATION SYSTEM FS19 NA manufactured by Torax Medical, Inc..
[100844797]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient was found to have fenix beads eroded through the anal canal 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) 2016. A flexible sigmoidoscopy on (b)(6) 2017 showed 4 beads exposed at the posterior anal canal. The patient's exposure symptoms began 2 months prior to the erosion discovery. Uneventful device explant (b)(6) 2017 due to 4 fenix device beads found eroded through the posterior anal canal. The fenix device was removed through the original incision. The device was intact at the time of explant. It was observed that the device "was well integrated into the soft tissue" at the time of explant. The patient was reported as "doing okay" after removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2018-00026 |
| MDR Report Key | 7293805 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-28 |
| Date of Event | 2017-06-09 |
| Date Mfgr Received | 2018-01-28 |
| Device Manufacturer Date | 2015-02-04 |
| Date Added to Maude | 2018-02-23 |
| 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 | 2018-02-23 |
| Model Number | FS19 |
| Catalog Number | NA |
| Lot Number | 7541 |
| Device Expiration Date | 2019-02-04 |
| 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 | 2018-02-23 |