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 FS20 NA manufactured by Torax Medical, Inc..
[102451180]
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) 2015. 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) 2015 with no adverse events from the procedure noted. -the patient presented to the clinic on (b)(6) 2016 with acute pain in the anus and reported having noticed blood. The device was found "inserted into the rectum from 11 o'clock to 10 o'clock and could be felt below the mucosa. " -patient admitted to the hospital for device explant on (b)(6) 2016. -uneventful device explant on (b)(6) 2016 due to fenix device erosion. The fenix device was intact. -patient was reported as doing well after explant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2018-00034 |
| MDR Report Key | 7340861 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-15 |
| Date of Report | 2018-02-13 |
| Date of Event | 2016-12-19 |
| Date Mfgr Received | 2018-02-13 |
| Device Manufacturer Date | 2013-08-08 |
| 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 | FS20 |
| Catalog Number | NA |
| Lot Number | 5078 |
| Device Expiration Date | 2017-08-08 |
| 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 |