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 2016-03-29 for FENIX CONTINENCE RESTRORATION SYSTEM FS14 NA manufactured by Torax Medical, Inc..
[41408267]
Following a surgical procedure for reinforcement of the anal sphnicter due to fecal incontinence, a patient experienced infection and rectal pain leading to erythema near the implant site and erosion of the fenix device 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 by dr (b)(6). Patient went to the hospital due to peri-anal pain and erythema around the surgical implant site on (b)(6) 2016. Patient was evaluated for crp levels and found to have an elevated level indicating an infection. The patient was administered analgesia and antibiotics. Patient returned to the hospital for severe peri-anal pain on (b)(6) 2016. The patient was examined and diagnosed with an erosion of the device through the anterior rectum. The patient was subsequently admitted and the device removed on (b)(6) 2016. The patient recovered in the hospital and was discharged on (b)(6) 2016 after completing a course of oral antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[49520710]
Following a surgical procedure for reinforcement of the anal sphnicter due to fecal incontinence, a patient experienced infection and rectal pain leading to erythema near the implant site and erosion of the fenix device 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 by dr. (b)(6). Patient went to the hospital due to peri-anal pain and erythema around the surgical implant site on (b)(6) 2016. Patient was evaluated for crp levels and found to have an elevated level indicating an infection. The patient was administered analgesia and antibiotics. Patient returned to the hospital for severe peri-anal pain on (b)(6) 2016. The patient was examined and diagnosed with an erosion of the device through the anterior rectum. The patient was subsequently admitted and the device removed on (b)(6) 2016. The patient recovered in the hospital and was discharged on (b)(6) 2016 after completing a course of oral antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2016-00024 |
| MDR Report Key | 5533170 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-03 |
| Date of Event | 2016-03-03 |
| Date Mfgr Received | 2016-03-03 |
| Device Manufacturer Date | 2013-08-12 |
| Date Added to Maude | 2016-03-29 |
| 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 | 2016-03-29 |
| Model Number | FS14 |
| Catalog Number | NA |
| Lot Number | 5101 |
| Device Expiration Date | 2017-08-12 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | TORAX MEDICAL, INC. |
| Manufacturer Address | 4188 LEXINGTON AVENUE N SHOREVIEW MN 55126 US 55126 |
| Brand Name | FENIX CONTINENCE RESTRORATION SYSTEM |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | PMH |
| Date Received | 2016-03-29 |
| Returned To Mfg | 2016-06-15 |
| Model Number | FS14 |
| Catalog Number | NA |
| Lot Number | 5101 |
| Device Expiration Date | 2017-08-12 |
| 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 | 2016-03-29 |