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 2017-01-20 for FENIX CONTINENCE RESTORATION SYSTEM FS17 NA manufactured by Torax Medical, Inc..
[65417360]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced anal pain 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. Uneventful device explant in fall 2016 due to anal pain. The incision healed well after device explant. After removal, the patient was still experiencing pain and was readmitted to the hospital for an mri. The mri was not able to establish the cause of pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2017-00008 |
| MDR Report Key | 6267030 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-20 |
| Date of Report | 2016-12-22 |
| Date Mfgr Received | 2016-12-22 |
| Device Manufacturer Date | 2015-02-05 |
| Date Added to Maude | 2017-01-20 |
| 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. JESSICA AHLBORN |
| 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 | 2017-01-20 |
| Model Number | FS17 |
| Catalog Number | NA |
| Lot Number | 7543 |
| Device Expiration Date | 2019-02-05 |
| 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 | 2017-01-20 |