MAUDE Adverse Event Report: WELLY HEALTH PBC WELLY BRAVERY BADGES ASSORTED CLASSIC VARIETY FLEX FABRIC BANDAGES; ADHESIVE BANDAGES

Model Number WLY1005

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

Patient Problems Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Date 12/12/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier, weight, race and ethnicity information were not provided.Device was used for treatment, not diagnosis.Device is not expected to be returned for manufacturer review/investigation since it is a single use bandage.Device evaluation/investigation could not be completed.No conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without the lot number.If information is obtained that was not available for the initial med-watch, an additional follow-up med-watch will be filed as appropriate.

Event Description

On 17-dec-2021, a spontaneous report from the united states was received via email from a consumer regarding a (b)(6) male who had a welly bravery badges associated assorted classic variety flex fabric bandage applied.The consumer had no known drug allergies.The consumer did not have any known medical history.No concomitant products were used.On (b)(6) 2021, a welly bravery badges associated assorted classic variety flex fabric bandage was topically applied to the child's left lower cheek/chin area for an unspecified indication.After 24-hours of bandage application, while the bandage was being removed a portion of the child's skin was peeled off in the shape of the bandage from the right side of the adhesive portion of the bandage.The child bleed from the injury.The reporter noted the bandage was soaked while he was bathing prior to puling it from his skin.For treatment of his symptoms an otc (over-the-counter) antibiotic cream was applied and the area was further bandaged.As of (b)(6) 2021, the injury was healing and it was uncertain if there would be any scarring.No additional information was provided.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.

• Brand Name: WELLY BRAVERY BADGES ASSORTED CLASSIC VARIETY FLEX FABRIC BANDAGES
• 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: jake schultz ; 30 s. 9th street, 7th floor; minneapolis, MN 55402 ; 6127153303
• MDR Report Key: 13227084
• MDR Text Key: 288996388
• Report Number: 3016050930-2022-00002
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 00810010440044
• UDI-Public: 00810010440044
• 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: Other
• Type of Report: Initial
• Report Date: 01/11/2022

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
• Device Model Number: WLY1005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/11/2022
• 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: 3 YR
• Patient Sex: Male