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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Irritation (1941); Itching Sensation (1943); Scar Tissue (2060); Caustic/Chemical Burns (2549); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

This has happened to me on three separate occasions after surgeries covering a span of 5 years.Drs will not take this seriously.Although i warn the drs to not use mastisol or any liquid adhesive containing the same ingredients on my skin (tincture of benzoin); they use it anyway while i am under anesthesia.Later they explain they "didn't think it would be this bad" or "had never seen any reaction this bad" so they thought it would still be ok to use.About 5 days after application mastisol causes extreme burning as if a flame is held to the skin.It burns deep below the surface of the skin.Then disgusting blisters that ooze pus develope and cover the entire area and the surrounding area.These blisters last for several months.All healing from the surgery is impeded.The itching and burning does not cease during this time.I have a scar from this as it looks like the skin melted and is shiny.When used on my feet after surgery, my feet appeared to have exploded and looked like raw hamburger meat.The bubbling blisters and sores burn as if on fire.It feels like acid has been poured on my skin.This last incident was a problem i dealt with for over 90 days and still got random pus bumps that came up for 6 months afterward.This drug should not be used on anything human.Reason for use: gluing skin after surgery, used to make gown-bandage stick.

• Brand Name: MASTISOL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ELOQUEST HEALTHCARE- FERNDALE LABORATORIES, INC.
• MDR Report Key: 9207932
• MDR Text Key: 162998971
• Report Number: MW5090465
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• 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: 10/13/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 59 YR
• Patient Weight: 70