DeRoyal 31-704Recalls & reported problems
Deroyal Industries, Inc. · WATER SOLUBLE LUBRICANT · Class 1
- 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 00749756028028), received between Aug 7, 2024 and Aug 7, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
Patient problems
- Foreign Body Reaction1
- Granuloma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 7, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
STERILE LUBRICANT USED DURING LIPOSUCTION PROCEDURE CONTAINS CARBOMER POLYMER WHICH CAUSED FOREIGN BODY REACTION AND IMPAIRED WOUND HEALING OF LIPOSUCTION SITES WITH GRANULOMAS.
Patient problems: Foreign Body Reaction; Granuloma
MAUDE report 19929647 ↗
Other Lubricant, patient devices
- DynaLube, Lubricating Jelly Sterile, 2.7 g Packet 1250Dynarex Corporation · Lubricant, Patient1 recall0 reports
- EnsoETM ECD02-AAdvanced Cooling Therapy, LLC · Lubricant, Patient5 reports
- EnsoETM ECD04-AAdvanced Cooling Therapy, LLC · Lubricant, Patient1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.