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 2016-09-08 for FENIX CONTINENCE RESTRORATION SYSTEM FS18 NA manufactured by Torax Medical, Inc..
[54266483]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced an infection and related symptoms (fever, rectal bleeding) 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 treated for infection with antibiotics several times including on (b)(6) 2016. All of these appointments showed that the surgical site had not fully healed. Wound dressing packed after (b)(6) 2016 appointment. Patient reported on (b)(6) 2016 some constipation which responded well to laxatives. Patient examination on (b)(6) 2016 showed that the implant site was infected and that the device was visible through the skin. Device explant on (b)(6) 2016 due to infection with associated symptoms. Wound site treated with gentamycin wash and packed with aquecel. Device was found in the correct position at time of explant. Patient had a follow-up exam on (b)(6) 2016 and it was reported that wound was healing well indicating the infection has been resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2016-00061 |
| MDR Report Key | 5937304 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-08 |
| Date of Report | 2016-08-08 |
| Date of Event | 2016-02-15 |
| Date Mfgr Received | 2016-08-08 |
| Device Manufacturer Date | 2015-03-13 |
| Date Added to Maude | 2016-09-08 |
| 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 | 2016-09-08 |
| Model Number | FS18 |
| Catalog Number | NA |
| Lot Number | 7783 |
| Device Expiration Date | 2019-03-13 |
| 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 | 2016-09-08 |