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 2016-05-17 for FENIX CONTINENCE RESTRORATION SYSTEM FS14 NA manufactured by Torax Medical, Inc..
[45365503]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced anal pain 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 in (b)(6) 2016 due to anal pain. Patient reported difficulty opening bowels despite laxatives. Device explanted through the perineal incision. It was reported no infection existed and device was found in correct position/geometry. One week post device explant patient reported "soreness", but the pain disappeared when the device was removed.
Patient Sequence No: 1, Text Type: D, B5
[50463258]
Patient reported return of incontinence (potentially worse than pre-implant) and obstructive defecation symptoms after device explant. Updated/corrected product code from mip to pmh based on availability of pmh code.
Patient Sequence No: 1, Text Type: N, H10
[50463259]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced anal pain 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 in (b)(6) 2016 due to anal pain. Patient reported difficulty opening bowels despite laxatives. Device explanted through the perineal incision. It was reported no infection existed and device was found in correct position/geometry. One week post device explant patient reported "soreness", but the pain disappeared when the device was removed.
Patient Sequence No: 1, Text Type: D, B5
[58268663]
Patient reported return of incontinence (potentially worse than pre-implant) and obstructive defecation symptoms after device explant. Patient's obstructive defecation resolved per proctogram test performed on (b)(6) 2016. Updated/corrected product code from mip to pmh based on availability of pmh code. Revised manufacture date from 08/12/2013 to 08/15/2013. Revised expiration date from 08/12/2017 to 08/15/2017. Revised patient age at time of event based on availability of date of birth.
Patient Sequence No: 1, Text Type: N, H10
[58268664]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced anal pain 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 in (b)(6) 2016 due to anal pain. Patient reported difficulty opening bowels despite laxatives. Device explanted through the perineal incision. The patient's difficulty opening bowels has resolved as of (b)(6) 2016. It was reported no infection existed and device was found in correct position/geometry. One week post device explant patient reported "soreness," but the pain disappeared when the device was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2016-00037 |
| MDR Report Key | 5661397 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-05-17 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-04-18 |
| Date Mfgr Received | 2016-09-28 |
| Device Manufacturer Date | 2013-08-15 |
| Date Added to Maude | 2016-05-17 |
| 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 | 2016-05-17 |
| 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 | R |
| 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 | 2016-05-17 |
| Model Number | FS14 |
| Catalog Number | NA |
| Lot Number | 5101 |
| Device Expiration Date | 2017-08-15 |
| 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. Deathisabilit | 2016-05-17 |