MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-21 for FENIX CONTINENCE RESTRORATION SYSTEM FXS20 NA manufactured by Torax Medical, Inc..
[60546665]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced dehiscence of the surgical wound leading to infection and then to fenix device explant. The fenix device was used as part of the surgical procedure. Surgical procedure and device implant on (b)(6) 2016. Patient experience constipation in the first week after implant and was prescribed laxatives. The patient then experienced diarrhea but then her stool consistency leveled out. The patient consulted her physician regarding wound drainage and was admitted to the hospital. The surgical wound was inspected and found to be 50% open but not red nor purulent. Examination showed the deeper suture were still intact with no exposure of the device. The patient was treated with iv antibiotics (ofloxacin/zocin). Patient reported that she was able to hold her bowels. Patient was reexamined on (b)(6) 2016 and the physician noted that the wound had opened up a "little bit more" but had stabilized on (b)(6) 2016 and discharged on (b)(6) 2016 device explant through surgical site on (b)(6) 2016 due to infection. Device was found correct position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2016-00092 |
| MDR Report Key | 6116684 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-21 |
| Date of Report | 2016-10-25 |
| Date of Event | 2006-10-25 |
| Date Mfgr Received | 2016-10-25 |
| Device Manufacturer Date | 2016-03-16 |
| Date Added to Maude | 2016-11-21 |
| 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 | MR. DANIEL HOSECK |
| 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 RESTRORATION SYSTEM |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | PMH |
| Date Received | 2016-11-21 |
| Model Number | FXS20 |
| Catalog Number | NA |
| Lot Number | 10526 |
| 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. Other | 2016-11-21 |