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

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

Patient Problems Pain (1994); Ulcer (2274); Skin Infection (4544)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device not returned for manufacturer review/investigation since it is single use bandage.Device evaluation by manufacturer could therefore not be completed.This report and the information submitted under this report do not constitute an admission that the device or welly health or any of its employees caused or contributed to the event described herein or that the event as reported to welly health actually occurred.

Event Description

On 25-jul-2022, a spontaneous report from the united states was received via email regarding a female (age not provided) who used welly bravery badges.Medical history included an ant bite on the arm which was intact and not open.The consumer was noted to have never had an infection before.The consumer had no known drug allergies nor skin allergies.Concomitant product usage was not provided.On an unspecified date in (b)(6) 2022, the consumer topically applied a welly bravery badge on her arm over an ant bite at night.The next morning after applying the bandage, it was hurting her.The bandage was removed and her parents noticed her bite area had started to turn more red and had puss.After her parents cleaned the area and put ointment on it, they covered the bite area again to keep it clean.By that evening the area was infected.Subsequently, her parents cleaned it again, put ointment on it, and left it uncovered.However, the infection already started.The next morning the area was the size of a golf ball and the skin had been eaten away.On (b)(6)2022, the consumer was taken to the doctor.On an unspecified date, she was healing atypically.No additional information was provided.

• Brand Name: WELLY BRAVERY BADGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): WELLY HEALTH PBC; 30 s. 9th street, 7th floor; MN 55402
• Manufacturer (Section G): WELLY HEALTH PBC; 30 s. 9th street, 7th floor; MN 55402
• Manufacturer Contact: jake schultz ; 30 s. 9th street, 7th floor; 6127153303
• MDR Report Key: 15266430
• MDR Text Key: 298317107
• Report Number: 3016050930-2022-00012
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2022

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female