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 2017-07-13 for FENIX CONTINENCE RESTORATION SYSTEM FS14 NA manufactured by Torax Medical, Inc..
[79947377]
Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence a patient was hospitalized overnight for constipation and impaction of feces leading to disimpaction intervention. The fenix device was used as part of the surgical procedure. -surgical procedure and device implant on (b)(6)2017. -patient was doing well post-op but had a reaction to antibiotics and stopped using them as instructed; bowels were hardened by (b)(6)2017. -patient was admitted to the hospital on (b)(6)2017 due to pain they were unable to tolerate. -patient was unable to pass feces and underwent manual evacuation under anesthesia on (b)(6)2017. The patient stayed overnight and underwent another manual evacuation on (b)(6)2017. -patient recovered and was discharged on (b)(6)2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2017-00077 |
| MDR Report Key | 6710774 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-13 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-06-12 |
| Date Mfgr Received | 2017-06-14 |
| Device Manufacturer Date | 2016-02-25 |
| Date Added to Maude | 2017-07-13 |
| 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 RESTORATION SYSTEM |
| Generic Name | IMPLANTED FECAL INCONTINENCE DEVICE |
| Product Code | PMH |
| Date Received | 2017-07-13 |
| Model Number | FS14 |
| Catalog Number | NA |
| Lot Number | 10342 |
| 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. Required No Informationntervention | 2017-07-13 |