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 2017-12-19 for FENIX CONTINENCE RESTORATION SYSTEM FS20 NA manufactured by Torax Medical, Inc..
[95238586]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced an infection leading to fenix device explant. The fenix device was used as part of the surgical procedure. Surgical procedure and device implant on (b)(6) 2017. It was noted during implant procedure that it was a "difficult dissection due to previous anterior repair". Patient admitted to the hospital on (b)(6) 2017 with c-reactive protein levels of 88 mg/l and complaining of lower abdominal and back pain. Patient was examined under anesthetic and a manual evacuation of the rectum was performed. It was observed that the perineal wound was "clean" with "no induration or infection". The patient was given analgesia and laxatives and discharged (b)(6) 2017. Infection symptoms began (b)(6) 2017. Uneventful device explant on (b)(6) 2017 due to infection; the device was removed through a "chromic sinus at 11 o'clock". The device was found in the correct position/geometry at the time of removal. It was reported that the there was "no obvious pus" and that the wound was "left partially open". Three weeks after implant, the patient's "wound was clean and dry on examination, no evidence of infection".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2017-00149 |
| MDR Report Key | 7128264 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-19 |
| Date of Report | 2017-11-23 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2017-11-23 |
| Device Manufacturer Date | 2015-07-29 |
| Date Added to Maude | 2017-12-19 |
| 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 | 2017-12-19 |
| Model Number | FS20 |
| Catalog Number | NA |
| Lot Number | 8660 |
| Device Expiration Date | 2019-07-29 |
| 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 | 2017-12-19 |