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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRAMER PRODUCTS THERABAND KINESIOLOGY TAPE; TAPE AND BANDAGE, ADHESIVE
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CRAMER PRODUCTS THERABAND KINESIOLOGY TAPE; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Lot Number 15755-23K
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Pain (1994); Rash (2033); Skin Irritation (2076); Swelling (2091)
Event Date 07/15/2019
Event Type  Injury  
Event Description
My skin on my left arm was injured while using theraband kinesiology tape distributed by (b)(4).I applied the tape as instructed and shown by a medical professional.The tape stayed on my arm for 24 hours much less than a maximum of 5 days.I noticed that my arm felt different and when i touched the area, my skin was raised.I slowly began removing the tape and there was a blister, redness, a rash, and my skin irritated and i was in pain for days following the injury.Before going to the dr, i wanted to give it a couple of days to see if it would get better by using pure shea butter.I nurtured the injury for more than a week and the blister and rash healed.Fda safety report id # (b)(4).
 
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Brand Name
THERABAND KINESIOLOGY TAPE
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
CRAMER PRODUCTS
MDR Report Key9383541
MDR Text Key168298321
Report NumberMW5091320
Device Sequence Number1
Product Code KGX
UDI-Device Identifier00087453127454
UDI-Public087453127454
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number15755-23K
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
COMPRESSION SLEEVES ; MULTIVITAMINS
Patient Outcome(s) Other;
Patient Age57 YR
Patient Weight54
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