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U.S. Department of Health and Human Services

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

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FERNDALE LABORATORIES, INC. MASTISOL; TAPE AND BANDAGE, ADHESIVE Back to Search Results
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.
 
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Brand Name
MASTISOL
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
FERNDALE LABORATORIES, INC.
MDR Report Key11805428
MDR Text Key250186546
Report NumberMW5101262
Device Sequence Number1
Product Code KGX
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
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 Received05/10/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age32 YR
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