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 2017-04-20 for FENIX CONTINENCE RESTORATION SYSTEM FS14 NA manufactured by Torax Medical, Inc..
[73329424]
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 rectum with associated pain and infection 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) 2017. Uneventful device explant (b)(6) 2017 due to visualization (erosion) of 8 beads of the fenix device in the anterior rectum with associated pain and infection. The fenix device was intact. Device explanted through the original incision. The patient was re-admitted to the hospital and had a colostomy on (b)(6) 2017 due to a rectocutaneous fistula. As of an appointment on (b)(6) 2017, the recto-anal wound started to granulate and the patient still had the temporary colostomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2017-00047 |
| MDR Report Key | 6509371 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-20 |
| Date of Report | 2017-03-24 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-03-24 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2017-04-20 |
| 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 | 2017-04-20 |
| Returned To Mfg | 2017-04-03 |
| Model Number | FS14 |
| Catalog Number | NA |
| Lot Number | 6825 |
| Device Expiration Date | 2018-10-01 |
| 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 | 2017-04-20 |