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 2018-06-14 for FENIX CONTINENCE RESTORATION SYSTEM FS18 NA manufactured by Torax Medical, Inc..
[111115122]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient was found to have one fenix bead eroded through the anal canal 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) 2014. Clinical examination on (b)(6) 2018 revealed "right anterior skin ulceration which showed part of the magnetic sphincter 1 cm from the anus". The patient reported recent perianal pain with "no fever or suspicious oozing". Uneventful device explant (b)(6) 2018 due to 1 fenix device bead found eroded through the anterior right anal canal. The entire fenix device was removed through the original incision. The device was intact at the time of explant. It was observed that "there is a fibrous perianal tunnel, but the anus is still gaping. The rectal mucosa is visible, but does not go past the marginal plane, even under traction". It was also observed that there was no infection at the exposure site. The patient was reported as "doing as well [as] its possible" after as of (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2018-00098 |
| MDR Report Key | 7603232 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-14 |
| Date of Report | 2018-05-16 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-05-16 |
| Device Manufacturer Date | 2012-07-11 |
| Date Added to Maude | 2018-06-14 |
| 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 | 2018-06-14 |
| Model Number | FS18 |
| Catalog Number | NA |
| Lot Number | 3740 |
| Device Expiration Date | 2016-07-11 |
| 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 | 2018-06-14 |