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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Rash (2033); Local Reaction (2035); Burning Sensation (2146); Fluid Discharge (2686)

Event Date 04/22/2021

Event Type  Injury  

Event Description

I had nose surgery and mastisol was placed to keep tape and caste on top of my nose in place.Three (3) days after my surgery i noticed a red rash forming around the tape.On day for it felt like my nose was on fire, so i called my surgeon and was advised to remove the tape and caste, and to remove the adhesive with acetone.My skin was so red and swollen, and oozing.I followed up in office 3 days later and my surgeon said it was the worst skin reaction to adhesive that he's ever seen, and that was 3 days after i'd removed the adhesive.I was even taking a medrol dose pack and daily antihistamine post surgery.The rash has gotten better with daily hydrocortisone 1%; 14 days after adhesive removal and rash still not fully resolved.

• Brand Name: MASTISOL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): FERNDALE LABORATORIES, INC.
• MDR Report Key: 11805428
• MDR Text Key: 250186546
• Report Number: MW5101262
• 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: Patient
• Type of Report: Initial
• Report Date: 05/06/2021

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: 05/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR