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 2016-11-22 for FENIX CONTINENCE RESTRORATION SYSTEM FS19 NA manufactured by Torax Medical, Inc..
[60743328]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced obstructed defecation and related symptoms (pain, impaction, constipation) leading to fenix device explant. The fenix device was used as part of the surgical procedure. Uneventful surgical procedure and device implant on (b)(4) 2014. Device explant on (b)(4) 2016 due to obstructed defecation. It was noted that the device was densely embedded in fibrotic tissue around the anal canal and required both anterior and posterior incisions for device explant. -he device was found in the correct position/geometry at the time of explant.
Patient Sequence No: 1, Text Type: D, B5
[63827444]
-addition to patient status after removal (wound healing well and patient experiencing pre-implant fi symptoms) -addition to an additional test performed after removal (flexible sigmoidoscopy) -addition to completed device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[63827665]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced obstructed defecation and related symptoms (pain, impaction, constipation) 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. -device explant on (b)(6) 2016 due to obstructed defecation. It was noted that the device was densely embedded in fibrotic tissue around the anal canal and required both anterior and posterior incisions for device explant. -the device was found in the correct position/geometry at the time of explant. -patient was reported as having return of fi and rectal bleeding on (b)(6) 2016 and healing well on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2016-00096 |
| MDR Report Key | 6122936 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-22 |
| Date of Report | 2016-11-29 |
| Date of Event | 2016-10-26 |
| Date Mfgr Received | 2016-11-29 |
| Device Manufacturer Date | 2012-07-16 |
| 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 | 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 | 2016-11-22 |
| Returned To Mfg | 2016-11-14 |
| Model Number | FS19 |
| Catalog Number | NA |
| Lot Number | 3742 |
| Device Expiration Date | 2016-07-16 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-11-22 |