PostFree 3105000801Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327376340), received between Oct 3, 2018 and Dec 23, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (4 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED COMPARTMENT SYNDROME FROM THE BOOT. SHE HAD A HIGH BMI AND WAS PLACED IN A SIZE 8 BOOT. HER CALVES WERE LARGE AND THE SETUP CREATED PRESSURE. THE LEG INVOLVED WAS THE NON TRACTION LEG.

  Patient problems: Compartment syndrome

  MAUDE report 23882688 ↗
• MalfunctionFeb 11, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WERE POST OP SENSATION ISSUES IN THE FEET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9694282 ↗
• MalfunctionFeb 11, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WERE POST OP SENSATION ISSUES IN THE FEET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9694280 ↗
• MalfunctionFeb 11, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WERE POST OP SENSATION ISSUES IN THE FEET.

  Patient problems: No Code Available

  MAUDE report 9694278 ↗
• MalfunctionJan 29, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS POST OP NUMBNESS.

  Patient problems: Numbness

  MAUDE report 9644975 ↗
• InjuryOct 3, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP PAIN OCCURED AS A RESULT OF PROLONGED TRACTION.

  Patient problems: Pain

  MAUDE report 7931389 ↗