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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Irritation (1941)

Event Type  Injury  

Event Description

I had gotten my nexplanon implant removed from my arm 5 days ago, and yesterday i realized the mastisol that was used on my wound closure caused a welt to form underneath the steri-strips that were placed on my arm.I've yet to be diagnosed with anything concerning this issue, but i felt that the allergy /issue still needed to be shared with the fda.Fda safety report id# (b)(4).

• Brand Name: MASTISOL
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): FERNDALE LABORATORIES, INC.
• MDR Report Key: 8692788
• MDR Text Key: 147931184
• Report Number: MW5087301
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/08/2019

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR