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 2016-11-22 for FENIX CONTINENCE RESTORATION SYSTEM FXS19 NA manufactured by Torax Medical, Inc..
[60742281]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced fecal incontinence (lack of effect) 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 on (b)(6) 2016. Device was found in correct position/geometry at the time of explant.
Patient Sequence No: 1, Text Type: D, B5
[63819962]
-addition to include disability or permanent damage now that reason for removal is confirmed as unhealed perforation during implant procedure. -addition to include vaginal wall perforation and suture repair during implant surgery on (b)(6) 2016. -addtion to include device protruding through suture repair site. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63819963]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced a perforation of the vaginal wall during implant which was still present at follow up visit leading to fenix device explant. The fenix device was used as part of the surgical procedure. -surgical procedure and device implant on (b)(6) 2016 that included a posterior perforation of the vaginal wall during dissection which was sutured shut before the device implant. -a follow up visit noted the device protruded through the posterior vaginal wall at the site of the suture repair and an uneventful device explant occurred on (b)(6) 2016. -device was found in correct position/geometry at the time of explant.
Patient Sequence No: 1, Text Type: D, B5
[73126594]
Include disability or permanent damage now that reason for removal is confirmed as unhealed perforation during implant procedure. Include vaginal wall perforation and suture repair during implant surgery on (b)(6) 2016. Include device protruding through suture repair site. Follow up report 2 included the removal of "device found in correct position/geometry at the time of explant".
Patient Sequence No: 1, Text Type: N, H10
[73126595]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced a perforation of the vaginal wall during implant which was still present at follow up visit leading to fenix device explant. The fenix device was used as part of the surgical procedure. -surgical procedure and device implant on (b)(6) 2016 that included a posterior perforation of the vaginal wall during dissection which was sutured shut before the device implant. -a follow up visit noted the device protruded through the posterior vaginal wall at the site of the suture repair and an uneventful device explant occurred on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2016-00097 |
| MDR Report Key | 6123053 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-22 |
| Date of Report | 2017-04-13 |
| Date of Event | 2016-10-24 |
| Date Mfgr Received | 2017-04-13 |
| Device Manufacturer Date | 2016-02-04 |
| Date Added to Maude | 2016-11-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2016-11-22 |
| Model Number | FXS19 |
| Catalog Number | NA |
| Lot Number | 10061 |
| 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. Other; 3. Deathisabilit | 2016-11-22 |