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 2018-03-15 for FENIX CONTINENCE RESTORATION SYSTEM FS15 NA manufactured by Torax Medical, Inc..
[102451417]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced an erosion of the fenix device into the anal canal leading to device explant. The fenix device was used as part of the surgical procedure. -uneventful surgical procedure and device implant on (b)(6) 2016. The patient was given pre-op prophylactic antibiotics. A pelvic x-ray was taken during the implant procedure showing the device in an acceptable position. -patient was discharged from the hospital on (b)(6) 2018. An x-ray was taken prior to discharge showing the device in an acceptable position. No adverse events from the surgery were noted. -the patient had severe constipation and had to "evacuate stool manually, causing injury to the rectum membrane and eroding the implant in the rectum. " -the erosion was discovered at "12 o'clock anal" on (b)(6) 2017 during an examination. -patient admitted to the hospital for device explant on (b)(6) 2017. -uneventful device explant on (b)(6) 2017 due to fenix device erosion. The fenix device was intact. -patient was discharged from the hospital on (b)(6) 2017. -patient was reported as doing well after explant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2018-00035 |
| MDR Report Key | 7340859 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-15 |
| Date of Report | 2018-02-13 |
| Date of Event | 2017-02-14 |
| Date Mfgr Received | 2018-02-13 |
| Device Manufacturer Date | 2012-07-09 |
| Date Added to Maude | 2018-03-15 |
| 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 | 2018-03-15 |
| Returned To Mfg | 2018-03-06 |
| Model Number | FS15 |
| Catalog Number | NA |
| Lot Number | 3736 |
| Device Expiration Date | 2016-07-09 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-03-15 |