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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Blister (4537); Contact Dermatitis (4546); Alteration in Body Temperature (4568)

Event Date 06/24/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, had surgery to plate right radius/ulna fracture.On or around (b)(6) 2021, felt hot, rash and blisters under cast.On (b)(6) 2021 went to normal orthopedic surgical follow up and found allergic contact dermatitis (acd) in the area where mastisol was applied to close wound with steristrips.Large fluid-filled bullae are present.

• Brand Name: MASTISOL, STERISTRIPS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): FERNDALE LABORATORIES, INC.
• MDR Report Key: 12107501
• MDR Text Key: 260054365
• Report Number: MW5102251
• 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: Unknown
• Type of Report: Initial
• Report Date: 06/29/2021

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: 07/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 96