Flowtron FG100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15055982700754), received between Jan 16, 2025 and Jan 16, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2025Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED TO THE SWEDISH MEDICAL PRODUCTS AGENCY, THE FOLLOWING: "FG 200 HAS BEEN PUT ON SO THAT WADING IS MISSING OVER AREA FOR N. THE COURSE OF THE PERONEUS OVER THE ANKLE." "SENSORY IMPAIRMENT OVER THE BIG TOE AND ADJACENT TOE. DROP FOOT WHEN INVERSION ABILITY REDUCED." THE CUSTOMER REPORTED IN THEIR REPORT THAT THE PATIENT WAS USING GARMENT SIZE FG200. HOWEVER, LOT NUMBER PROVIDED, INDICATES THAT THE GARMENT THAT WAS USED WAS FG100. THE DIFFERENCE BETWEEN THOSE TWO GARMENTS REFER TO FOOT SIZE. FG IS SMALLER THAN FG200. INFORMATION ALONG WITH PICTOGRAMS REGARDING GARMENTS SIZE, AND HOW TO APPLY THE GARMENTS ONTO THE FOOT ARE INCLUDED IN THE PRODUCT INSTRUCTION FOR USE, GARMENT SIZING AND APPLICATION GUIDE, ALSO GARMENT HAS PRINTING SHOWING THE SIZE AND PROPER APPLICATION. THE GUIDANCE AND INSTRUCTIONS FOR USE ARE DELIVERED TO THE CUSTOMER WITH EVERY GARMENT DELIVERY. THE PHOTOGRAPHIC PIECE OF EVIDENCE PROVIDED SHOWS THAT THE GARMENT WAS PLACED ON THE HEEL PART OF THE FOOT, WHICH IS NOT IN ACCORDANCE TO THE PRODUCT LABELLING. THE FOOT GARMENT HAS FOUR FLAPS, TWO FLAPS ARE FOLDED OVER THE SINGLE FLAP ON THE TOP OF THE FOOT. THE FOURTH FLAT GOES AROUND THE HEEL. THE CUSTO

  Patient problems: Insufficient Information

  MAUDE report 21172527 ↗
• InjuryJan 16, 2025Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED TO THE SWEDISH MEDICAL PRODUCTS AGENCY, THE FOLLOWING: "FG 200 HAS BEEN PUT ON SO THAT WADING IS MISSING OVER AREA FOR N. THE COURSE OF THE PERONEUS OVER THE ANKLE." "SENSORY IMPAIRMENT OVER THE BIG TOE AND ADJACENT TOE. DROP FOOT WHEN INVERSION ABILITY REDUCED." THE CUSTOMER REPORTED IN THEIR REPORT THAT THE PATIENT WAS USING GARMENT SIZE FG200. HOWEVER, LOT NUMBER PROVIDED, INDICATES THAT THE GARMENT THAT WAS USED WAS FG100. THE DIFFERENCE BETWEEN THOSE TWO GARMENTS REFER TO FOOT SIZE. FG IS SMALLER THAN FG200. INFORMATION ALONG WITH PICTOGRAMS REGARDING GARMENTS SIZE, AND HOW TO APPLY THE GARMENTS ONTO THE FOOT ARE INCLUDED IN THE PRODUCT INSTRUCTION FOR USE, GARMENT SIZING AND APPLICATION GUIDE, ALSO GARMENT HAS PRINTING SHOWING THE SIZE AND PROPER APPLICATION. THE GUIDANCE AND INSTRUCTIONS FOR USE ARE DELIVERED TO THE CUSTOMER WITH EVERY GARMENT DELIVERY. THE PHOTOGRAPHIC PIECE OF EVIDENCE PROVIDED SHOWS THAT THE GARMENT WAS PLACED ON THE HEEL PART OF THE FOOT, WHICH IS NOT IN ACCORDANCE TO THE PRODUCT LABELLING. THE FOOT GARMENT HAS FOUR FLAPS, TWO FLAPS ARE FOLDED OVER THE SINGLE FLAP ON THE TOP OF THE FOOT. THE FOURTH FLAT GOES AROUND THE HEEL. THE CUSTO

  Patient problems: Insufficient Information; Nerve Damage

  MAUDE report 21166610 ↗