traxi® Panniculus Retractor PRS-1030Recalls & reported problems
Clinical Innovations, LLC · Traxi Panniculus Retractor with Retentus Technology (BMI 30-50) · Class 1
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 00814247020345), received between Apr 26, 2022 and Apr 26, 2022 — 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
- Peeling1
- Skin Burning Sensation1
- Skin Erosion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem
"PATIENT EXPERIENCED TWO SMALL AREAS OF SKIN BREAKDOWN AND DISCOMFORT UPON REMOVAL OF TRAXI. PEELING SKIN AND BURNING IN THOSE AREAS WHEN SHOWERING."
Patient problems: Peeling; Skin Burning Sensation; Skin Erosion
MAUDE report 14211263 ↗
Other Support, Patient Position devices
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- DeRoyal 8000HDPDeroyal Industries, Inc. · SUPPORT, PATIENT POSITION16 reports
- PILLOW, GENTLETOUCH, 7 INCH RT 1937Mizuho Orthopedic Systems, Inc. · Support, Patient Position11 reports
- Battalion 27428Alphatec Spine, Inc. · SUPPORT, PATIENT POSITION3 reports
- ACUFEX 72205103Smith & Nephew, Inc. · SUPPORT, PATIENT POSITION2 reports
- Medline MSC50023Medline Industries, Inc. · SUPPORT, PATIENT POSITION2 reports
- MEDLINE NON081147Medline Industries, Inc. · SUPPORT, PATIENT POSITION2 reports
- Olympic Vac-Pac Size 30Natus Medical Incorporated · Support, Patient Position2 reports
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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