MAUDE Adverse Event Report: WELLY HEALTH PBC WELLY HEROIC BANDAGE KIT; ADHESIVE BANDAGES

Device Problem Insufficient Information (3190)

Patient Problem Skin Tears (2516)

Event Date 12/15/2022

Event Type  Injury  

Manufacturer Narrative

Information regarding associated case (2022-us-029552) was also provided by the fda (mw5113868).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 occurred.

Event Description

On 15-dec-2022, a spontaneous report from the united states was received via email regarding a female (age not provided) consumer who used a welly heroic bandage kit.Medical history included allergies to "medical" adhesives which cause localized itching and redness after a day or two of continuous use and a hidradenitis suppurativa lesion on her inner thigh.The consumer noted she did not have sensitive or delicate skin.Further medical history and concomitant product usage were not provided.On (b)(6) 2022 the consumer topically applied a heroic bandage to cover a hidradenitis suppurativa lesion on her inner thigh.On 19-dec-2022, additional information was received from the consumer.On 30-dec-2022, additional information was received from a consumer via the fda (mw5113868).On the evening of (b)(6) 2022 after wearing the bandage for 12 hours, she removed it.While removing it she tore skin off which left a wound.She dressed the new wound and applied mupirocin to try to prevent an infection.She noted that putting on bandages anywhere, but the back of her arm seemed to carry a risk of avulsion when she takes them off.She was worried that she would potentially develop cellulitis.As of (b)(6) 2022 she was treating herself at home and did not show any signs of infection.No additional information was provided.The reporter also provided information regarding the associated case: 2022-us-029552.

• Brand Name: WELLY HEROIC BANDAGE KIT
• 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: 16127065
• MDR Text Key: 306985090
• Report Number: 3016050930-2023-00002
• 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: 01/09/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/09/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female