MAUDE Adverse Event Report: WELLY HEALTH PBC WELLY BRAVERY BADGES DINOSAUR ADHESIVE BANDAGE; ADHESIVE BANDAGES

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

Patient Problems Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907)

Event Date 10/15/2022

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 (b)(6) 2022, a spontaneous report from the united states was received via telephone regarding a 4-year-old female who used a welly bravery badges dinosaur adhesive bandage.The consumer had no medical history, known allergies, or prior sensitivities to other bandages.On (b)(6) 2022, the child had a welly bravery badges dinosaur adhesive bandage applied to her chin.On 17-oct-2022, additional information was provided.On (b)(6) 2022, when the bandage was removed, the skin under the adhesive looked raw.It was bleeding as she had a burn from the bandage.For treatment, the area was cleaned, neosporin and another branded bandage were applied.On (b)(6) 2022, it was clarified that her mother thought there were two areas of concern on the child's chin from the adhesive on both sides.One side healed nicely without concern, but the other side formed a large scab.The mother was concerned the area would scar once the scab fell off.The scab formed over the past 24 hours.It was originally covered and now it was left open to air.The neosporin was just applied for the first day.Her mother considered taking the child in to be evaluated but she decided just to monitor it at home.No additional information was provided.

• Brand Name: WELLY BRAVERY BADGES DINOSAUR ADHESIVE BANDAGE
• Type of Device: ADHESIVE BANDAGES
• Manufacturer (Section D): WELLY HEALTH PBC; 30 s. 9th street, 7th floor; minneapolis MN 55402
• Manufacturer (Section G): WELLY HEALTH PBC; 30 s. 9th street, 7th floor; minneapolis MN 55402
• Manufacturer Contact: joe ciccone ; 30 s. 9th street, 7th floor; minneapolis, MN 55402 ; 8565811481
• MDR Report Key: 15744293
• MDR Text Key: 303166127
• Report Number: 3016050930-2022-00014
• 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: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• 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
• Date Manufacturer Received: 10/15/2022
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Sex: Female