MAUDE Adverse Event Report: WELLY HEALTH PBC BRAVERY BADGES; TAPE AND BANDAGE, ADHESIVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Scar Tissue (2060); Skin Tears (2516); Skin Infection (4544)

Event Date 07/01/2022

Event Type  Injury  

Event Description

I had a pimple on my breast, which i covered with a welly brand adhesive bandage.When i removed the bandage, a roughly 1 cm square area of epidermis was torn off by the bandage, not at the location of the original pimple.I had difficulty keeping the wound covered and it got infected.On (b)(6) 2022, i saw a doctor via telemedicine and showed her photos of the wound, and she diagnosed me with cellulitis and treated me with mupirocin and a course of cephalexin.The wound healed but left a large scar.Today, (b)(6) 2022, i removed another adhesive bandage of the same brand that i had used to cover a hidradenitis suppurativa lesion on my inner thigh, and it also tore skin off with it, leaving an almost identical wound to that i received on (b)(6) 2022.I have dressed the new wound and applied mupirocin to try and prevent another infection, but i'm worried i will get cellulitis there as well.I'm also extremely concerned because welly markets their bandages for use on children, who i feel are likely to have more delicate skin than i do.

• Brand Name: BRAVERY BADGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WELLY HEALTH PBC
• MDR Report Key: 16016441
• MDR Text Key: 305978729
• Report Number: MW5113868
• Device Sequence Number: 1
• 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: 12/15/2022

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2022
• Patient Sequence Number: 1
• Treatment: B-VITAMIN COMPLEX, VITAMIN B-2, MAGNESIUM, IBUPROFEN, CETIRIZINE, DIPHENHYDRAMINE, PHENYLEPHRINE.; NEXPLANON, FLUNISOLIDE NASAL SPRAY, ALBUTEROL, BUDESONIDE/FORMOTEROL, GABAPENTIN, SERTRALINE, SPIRONOLACTONE, LEVOTHYROXINE.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 127 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White