FENIX FXS-[20]Recalls & reported problems
Torax Medical, Inc. · Class f · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855106005530), received between Nov 21, 2016 and Nov 21, 2016 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Post Operative Wound Infection1
- Wound Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FOLLOWING A SURGICAL PROCEDURE FOR REINFORCEMENT OF THE ANAL SPHINCTER DUE TO FECAL INCONTINENCE, A PATIENT EXPERIENCED DEHISCENCE OF THE SURGICAL WOUND LEADING TO INFECTION AND THEN 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 EXPERIENCE CONSTIPATION IN THE FIRST WEEK AFTER IMPLANT AND WAS PRESCRIBED LAXATIVES. THE PATIENT THEN EXPERIENCED DIARRHEA BUT THEN HER STOOL CONSISTENCY LEVELED OUT. THE PATIENT CONSULTED HER PHYSICIAN REGARDING WOUND DRAINAGE AND WAS ADMITTED TO THE HOSPITAL. THE SURGICAL WOUND WAS INSPECTED AND FOUND TO BE 50% OPEN BUT NOT RED NOR PURULENT. EXAMINATION SHOWED THE DEEPER SUTURE WERE STILL INTACT WITH NO EXPOSURE OF THE DEVICE. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS (OFLOXACIN/ZOCIN). PATIENT REPORTED THAT SHE WAS ABLE TO HOLD HER BOWELS. PATIENT WAS REEXAMINED ON (B)(6) 2016 AND THE PHYSICIAN NOTED THAT THE WOUND HAD OPENED UP A "LITTLE BIT MORE" BUT HAD STABILIZED ON (B)(6) 2016 AND DISCHARGED ON (B)(6) 2016 DEVICE EXPLANT THROUGH SURGICAL SITE ON (B)(6) 2016 DUE TO INFECTION. DEVICE WAS FOUND CORRECT POSITION.
Patient problems: Post Operative Wound Infection; Wound Dehiscence
MAUDE report 6116684 ↗
Other Mechanical Compression Device Fecal Incontinence (Non-Manually Operated) devices
- FENIX FXS-[19]Torax Medical, Inc. · Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)2 reports
- FENIX FXS-[15]Torax Medical, Inc. · Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)1 report
- FENIX FXS-[17]Torax Medical, Inc. · Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)1 report
- FENIX FXS-[16]Torax Medical, Inc. · Mechanical Compression Device Fecal Incontinence (Non-Manually Operated)1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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