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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Swelling (2091); Chills (2191); Sweating (2444)

Event Date 08/31/2018

Event Type  Injury  

Event Description

Severe allergic reaction included large blistering, itching, profuse sweating with chills, gastro-intestinal upset.I had surgery on (b)(6) 2018, and my itching started about 4 days later.I thought it was just healing, but it worsened.I contacted my dr who wanted me to leave the strip on, which turned out to be the wrong call as it was actually the adhesive which was causing the problem.Finally, a week into this, i took my bandage off and saw my foot was red.It was also very itchy and painful.I could no longer wear my cast.Ten days after surgery, i started to have profuse sweating and chills along with diarrhea, and the next morning my foot was covered in large blisters.It felt like someone had mixed acid and itching powder and taped it onto my foot.I had no warning of this at all.I see that there is a one line "some people have reported allergic reaction to mastisol" on the package.That's it, if i had acquired an infection through all the raw and blistered skin.I would be in the hosp.As it is, i cannot walk due to the pain, and my foot will be severely scarred.This is why testing on non-human animals does not work.This product was approved, but there are plenty of people who are suffering (including newborns) because a patch test was not done.Inexcusable.I have pictures, by the way.If you want to see more stories and pictures you can go to (b)(6).

• Brand Name: MASTISOL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ELOQUEST HEALTHCARE INC. / FERNDALE LABORATORIES, INC.
• MDR Report Key: 7889212
• MDR Text Key: 120868290
• Report Number: MW5079877
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 73