MAUDE Adverse Event Report: ELOQUEST HEALTHCARE / FERNDALE LABORATORIES, INC. MASTISOL; TAPE AND BANDAGE, ADHESIVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Fluid Discharge (2686); Blister (4537)

Event Date 05/29/2021

Event Type  Injury  

Event Description

Had a severe case of contact dermatitis related to the use of mastisol following the removal of two lipomas.Blistering, itching, and fluid discharge were so severe that they prevented me from working for several days as dressings and bandages would rapidly soak through and ruin clothing.

• Brand Name: MASTISOL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ELOQUEST HEALTHCARE / FERNDALE LABORATORIES, INC.
• MDR Report Key: 11946531
• MDR Text Key: 254894805
• Report Number: MW5101730
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 108