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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Rash (2033); Discharge (2225)

Event Date 01/04/2019

Event Type  Injury  

Event Description

Mastisol glue was applied to secure steri-strips to hold 2 incisions together after stitches were removed.I experienced severe rash, blistering, and oozing for 2 weeks following.Note consumer reports on mastisol on webmd: 74 reports of same problems i had.Did the problem stop after the person reduced the dose or stopped taking or using the product? no.

• Brand Name: MASTISOL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): FERNDALE LABORATORIES, INC
• MDR Report Key: 8306201
• MDR Text Key: 135679347
• Report Number: MW5083694
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 76 YR
• Patient Weight: 54