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

Device Problem Melted (1385)

Patient Problems Inflammation (1932); Itching Sensation (1943); Burning Sensation (2146)

Event Date 06/29/2022

Event Type  Injury  

Event Description

Mastisol applied after cancer surgery to adhere bandage to chest area.Within hours skin began to have extreme itching, extreme burning sensation, skin became inflamed red color.Twenty-four hours later bandage was removed and discovered the bandage had melted and glue substance was stuck to skin.Required goo-gone, mineral oil to remove melted material.Extreme itching and burning sensation continued for about 5 days.Applied various topical treatments to mitigate the pain.Fda safety report id # (b)(4).

• Brand Name: MASTISOL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): FERNDALE LABORATORIES, INC.
• MDR Report Key: 15016428
• MDR Text Key: 296042328
• Report Number: MW5110863
• 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: 07/12/2022

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2022
• Patient Sequence Number: 1
• Treatment: SIMVATATIN
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White