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 2017-10-23 for FENIX CONTINENCE RESTORATION SYSTEM FS16 NA manufactured by Torax Medical, Inc..
[90036587]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced anal pain and perineal inflammation 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) 2013. - patient began having worsening symptoms on (b)(6) 2016. - uneventful device explant on (b)(6) 2017 due to anal pain and perineal inflammation; the device was removed through the original incision. - the device was found in the correct position/geometry at the time of removal. - patient is "doing well" as of (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2017-00121 |
| MDR Report Key | 6970070 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-23 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-11-08 |
| Device Manufacturer Date | 2011-11-18 |
| Date Added to Maude | 2017-10-23 |
| 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 | 2017-10-23 |
| Model Number | FS16 |
| Catalog Number | NA |
| Lot Number | 3176 |
| Device Expiration Date | 2015-11-18 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-10-23 |