MAUDE Adverse Event Report: ELOQUEST HEALTHCARE / FERNADALE LABORATORIES, INC MASTISOL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Irritation (1941); Pain (1994); Swelling (2091); Discharge (2225)

Event Date 02/12/2019

Event Type  Injury  

Event Description

I had a left lapidus bunionectomy on (b)(6) 2019 at (b)(6) surgery center in (b)(6).I was told on (b)(6) to loosen the bandage after i sought medical device via the nurseline and that would help with the intense pain i felt.The pain changed in the coming days.Over the next week i could see it getting more red, irritated.On (b)(6) i removed the bandage to look at what was happening, knowing i had an appointment at 4 pm on (b)(6).The top of my foot was covered with burning, bubbling, blisters.One had broken open and continuously oozed.I called the doctor on (b)(6) and moved my appointment to their earliest available, 1 pm.Within moments of them unwrapping, the doctor noted that i must be allergic to the mastisol he used to adhere the zipline.He said he had seen it 2-3x before and that it was clear exactly where it was applied was where the blisters were.Doctor applied to help adhere zipline post-surgery.

• Brand Name: MASTISOL
• Type of Device: MASTISOL
• Manufacturer (Section D): ELOQUEST HEALTHCARE / FERNADALE LABORATORIES, INC
• MDR Report Key: 8343580
• MDR Text Key: 137005228
• Report Number: MW5084105
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• 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: 32 YR
• Patient Weight: 63