MAUDE Adverse Event Report: WELLY HEALTH PBC WELLY FACE SAVER; DRESSING, WOUND, HYDROPHILIC

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

Patient Problems Erythema (1840); Ulcer (2274); Skin Inflammation/ Irritation (4545)

Event Date 07/22/2023

Event Type  Injury  

Manufacturer Narrative

The device was used for treatment, not diagnosis.Device was not returned for manufacturer review/investigation since it is single use bandage.Device evaluation by the 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

This spontaneous report was received via email on 06-aug-2023 on behalf of a 5-year-old, female consumer regarding her use of welly health's face savers.Medical history included an unspecified skin condition described as "skin irritations." the parent of the consumer who experienced the event reported that during the weekend of (b)(6) 2023, a face saver was applied to an area of skin that was irritated in unspecified locations and attempted to use the product as directed on the package instructions.The consumer had a history of recurrent, irritated skin areas that required an ongoing care regimen that included medicating and bandaging affected areas.An unspecified amount of time after application of the face saver, the consumer developed worsening irritation, redness and swelling of the affected area that eventually evolved into sores on her skin.The product was removed, however, the skin sores continued to worsen.On an unspecified date, the consumer's pediatrician was contacted via email.On 24-jul-2023, the physician responded advising that alternative bandaging be used along with the consumer's normal skin care regimen which included sensitive-skin soaps and lotions along with the application of topical benadryl (diphenhydramine) and neosporin as needed.On (b)(6) 2023 the consumer reported that the areas experiencing the adverse conditions in which the face savers were applied worsened requiring prescribed medications.

• Brand Name: WELLY FACE SAVER
• Type of Device: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): WELLY HEALTH PBC; 700 nicollet mall, suite 800; minneapolis MN 55402
• Manufacturer (Section G): WELLY HEALTH PBC; 700 nicollet mall, suite 800; MN 55402
• Manufacturer Contact: joe ciccone ; 700 nicollet mall, suite 800; 8565811481
• MDR Report Key: 17665721
• MDR Text Key: 322471637
• Report Number: 3016050930-2023-00005
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 00810010441775
• UDI-Public: 810010441775
• 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: 08/31/2023

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: 08/06/2023
• Initial Date FDA Received: 08/31/2023
• 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
• Treatment: GUMMY MULTIVITAMIN.; ORAL ANTIBIOTIC.; ORAL ANTIHISTAMINES.; TOPICAL ANTIBIOTICS.; TOPICAL ANTIFUNGALS.; TOPICAL STEROIDS.; VITAMIN D.
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Sex: Female