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

Model Number WLY1045

Device Problem Insufficient Information (3190)

Patient Problem Local Reaction (2035)

Event Type  Injury  

Manufacturer Narrative

Manufacturer narrative: device was used for treatment, not diagnosis.Device not returned for manufacturer review/investigation since it is a single use bandage.Device evaluation by manufacturer could therefore not be completed.Additional information was not obtained from the user when our customer response team tried to reach the user again.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 email regarding a female consumer (age not provided) who used a welly bravery badges colorwash adhesive bandage.Medical history an unspecified knee injury.Concomitant products were not provided.On an unspecified date, a welly bravery badges colorwash adhesive bandage was topically applied over the consumer's knee injury.Approximately after three hours of applying the bandage, the affected area "grew".Subsequently, the consumer was taken to a doctor and had medication applied.No further information was provided.

Event Description

On 23-mar-2022, a spontaneous report from the united states was received via email regarding a female consumer (age not provided) who used a welly bravery badges colorwash adhesive bandage.Medical history an unspecified knee injury.Concomitant products were not provided.On an unspecified date, a welly bravery badges colorwash adhesive bandage was topically applied over the consumer's knee injury.Approximately after three hours of applying the bandage, the affected area "grew".Subsequently, the consumer was taken to a doctor and had medication applied.No further information was provided.

Manufacturer Narrative

Manufacturer narrative: device was used for treatment, not diagnosis.Device not returned for manufacturer review/investigation since it is a single use bandage.Device evaluation by manufacturer could therefore not be completed.Additional information was not obtained from the user when our customer response team tried to reach the user again.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.Corrected data: a correction report was submitted on 31-aug-2022 for case report 3016050930-2022-00010 to explain the prior submission.The original submission on 13-jun-2022 with date of awareness of 23-may-2022 was submitted within the 30 day time period with an incorrect fei number.On 15-aug-2022, the awareness of the prior submitted incorrect fei number was discovered.On 20-aug-2022, the original case information was re-submitted unaltered per cdrh with the correct fei number 3016050930-2022-00010.

Manufacturer Narrative

On 21-apr-2023, the month of the receipt of the report was updated to 23-may-2023 from 23-mar-2023.On 23-may-2022, a spontaneous report from the united states was received via email regarding a female consumer (age not provided) who used a welly bravery badges colorwash adhesive bandage.Medical history an unspecified knee injury.Concomitant products were not provided.On an unspecified date, a welly bravery badges colorwash adhesive bandage was topically applied over the consumer's knee injury.Approximately after three hours of applying the bandage, the affected area "grew".Subsequently, the consumer was taken to a doctor and had medication applied.No further information was provided.

• Brand Name: WELLY BRAVERY BADGES COLORWASH ADHESIVE BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• 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: 15263422
• MDR Text Key: 298282494
• Report Number: 3016050930-2022-00010
• 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,Followup,Followup
• Report Date: 04/26/2023

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: WLY1045
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 08/20/2022
• Supplement Dates Manufacturer Received: 08/15/2022; 04/21/2023
• Supplement Dates FDA Received: 08/31/2022; 04/26/2023
• 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 Sex: Female