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 2016-10-28 for FENIX CONTINENCE RESTRORATION SYSTEM FXS19 NA manufactured by Torax Medical, Inc..
[58711152]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced a pain and wound dehiscence 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. Patient was monitored for pain and prophylactically treated with antibiotics. Patient received iv antibiotics 13 days after implant and patient reported symptoms of constipation and pain. Device explant through surgical site on (b)(6) 2016 due to pain and would dehiscence. Physician reported that during device explant the device got hung up on a ligament. A clamp was applied to each end of the cut device and a "great deal of force" was applied; enough to break a device connecting wire. Device was found in the correct position at time of explant. Patient is recovering well.
Patient Sequence No: 1, Text Type: D, B5
[73011897]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73011898]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced a pain and wound dehiscence 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. -patient was monitored for pain and prophylactically treated with antibiotics. -patient received iv antibiotics 13 days after implant and patient reported symptoms of constipation and pain. -device explant through surgical site on (b)(6) 2016 due to pain and wound dehiscence. -physician reported that during device explant the device got hung up on a ligament. A clamp was applied to each end of the cut device and a "great deal of force" was applied; enough to break a device connecting wire. -device was found in the correct position at time of explant. -patient is recovering well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2016-00076 |
| MDR Report Key | 6064941 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-28 |
| Date of Report | 2017-04-10 |
| Date of Event | 2016-08-18 |
| Date Mfgr Received | 2017-04-10 |
| Device Manufacturer Date | 2016-02-04 |
| Date Added to Maude | 2016-10-28 |
| 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 RESTRORATION SYSTEM |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | PMH |
| Date Received | 2016-10-28 |
| 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 | 2016-10-28 |