MAUDE Adverse Event Report: ADHESIVE TAPE; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Scar Tissue (2060); Burning Sensation (2146)

Event Date 06/07/2021

Event Type  Injury  

Event Description

I am required to take drug tests as part of my child abuse assessment case and in (b)(6) 2021 a patch was put on my left arm.I worked, sweating and in the heat.I noticed it started burning where the patch was on my skin.I told my workers about it and they seem unconcerned.I do have an allergy to medical tape and when this patch was taken off on i was left with a red mark that was deep and it has not gone away.I have scarring on my arm from this device and am still required to wear it.I have contacted the company about it and have heard nothing in return.I just would like to know what to do.Pharmacheck drug sweat patch left scarring on my arm.I also question the validity of the patch as i hadn't been using but patches were coming up dirty.I question whether they can be contaminated by outside factors or collect sweat for longer periods of time than they say.Fda safety report id # (b)(4).

• Brand Name: ADHESIVE TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 13783050
• MDR Text Key: 287394564
• Report Number: MW5108181
• Device Sequence Number: 2
• 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: 03/13/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Patient Sequence Number: 1
• Treatment: ABILIFY; DRAGONS FRUIT; LEMON BLAM; MEDICAL MARIJJUANA CARD; TRAZADONE; TUMERIC ; ZINC; ZOLOFT
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White