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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Local Reaction (2035); Tissue Damage (2104); Fluid Discharge (2686)

Event Date 08/15/2017

Event Type  Injury  

Event Description

I had arthroscopic surgery on my right shoulder, 3 incisions.Mastisol was applied around each of the incision sites.Within 48 hrs, my incisions were itching so bad i had to remove the bandage.Each of the incision sites were a mass of draining blisters.You could literally watch them form and pop.I knew this was an allergic reaction to something, so i cleaned it up as best i could and applied some 1.5% cortisone foam to try to alleviate the severe itching.I saw the surgeon the following morning and he was shocked by what he saw.He changed the dressing and told me to continue using the cortisone foam.After another 24 hrs, it had improved significantly and took an add'l 3 or 4 days to mostly disappear.There is now a note in my records to never use mastisol again.It is a liquid adhesive to aid surgical dressings.

• Brand Name: MASTISOL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): FERNDALE LABORATORIES, INC.
• MDR Report Key: 8191499
• MDR Text Key: 131466511
• Report Number: MW5082509
• 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: 12/19/2018

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: 12/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 97