MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL INDUSTRIES WATER-SOLUBLE LUBRICANT; LUBRICANT, PATIENT

Model Number 31-704

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Foreign Body Reaction (1868); Granuloma (1876); Impaired Healing (2378)

Event Date 01/28/2022

Event Type  Injury  

Event Description

Sterile lubricant used during liposuction procedure contains carbomer polymer which caused foreign body reaction and impaired wound healing of liposuction sites with granulomas.

• Brand Name: DEROYAL INDUSTRIES WATER-SOLUBLE LUBRICANT
• Type of Device: LUBRICANT, PATIENT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.
• MDR Report Key: 16352981
• MDR Text Key: 309405177
• Report Number: MW5114846
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31-704
• Device Catalogue Number: 31-704
• Device Lot Number: 55912082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White