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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Skin Irritation (2076); Vomiting (2144); Burning Sensation (2146); Chills (2191)

Event Date 07/30/2019

Event Type  Injury  

Event Description

I had arthroscopic knee surgery (b)(6) 2019.On (b)(6), i removed the steri strips and noticed redness under the steri strips.The next morning i had red / raw skin all around the knee with some small blistering.Over the next several days the blisters continued to grow in size and quantity.I had three drs look at it over the next three days until one finally put me on prednisone.My surgeon believes i am allergic to mastisol and sent me to see an allergy specialist.By this time i was unable to bend my knee because of the blistering, and had chills, vomiting, trouble breathing, intense burning and itching.A rash continue to spread down the front of my leg almost to my ankle, but that area did not blister.I went to (b)(6), (b)(6) 2019 to see an allergy specialist who believes i had a rare severe allergic reaction to mastisol used during surgery.I return in a month to get tested since i have to be off and histamines and prednisone for 30 days.Once i was on the prednisone, the blisters and rash cleared up within a week.Fda safety report id# (b)(4).

• Brand Name: MASTISOL LIQUID
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): FERNDALE LABORATORIES, INC.
• MDR Report Key: 8892671
• MDR Text Key: 154437022
• Report Number: MW5088992
• 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: 08/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 73