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

Model Number WLY1061

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Skin Tears (2516)

Event Date 04/26/2022

Event Type  Injury  

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.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 regarding a 37-year-old female who used welly bravery badges space adhesive bandages.Medical history included a cancer diagnosis and a full hysterectomy (on (b)(6) 2022) with staples on her belly from surgery.Allergies included latex, perfumes, gain laundry detergent, and to prescriptions (not further specified).On (b)(6) 2022, she was discharged from the hospital and applied one welly bravery badges space adhesive bandage to the area where the hysterectomy surgery had been performed.On (b)(6) 2022, she applied a welly bravery badges space adhesive bandage.Upon removing the bandage the next morning, it ripped her skin off and it began to bleed.She immediately soaked up the blood.Once the blood stopped, she cleaned the area and applied bacitracin.She then applied gauze to the area with paper tape.The area was very painful.The area hurt more than when the bandage ripped off her skin.On (b)(6) 2022, she had a doctor appointment.Her doctor told her to completely discontinue the bandage, to continue to apply bacitracin, and keep it uncovered without a bandage or gauze of any kind.On (b)(6) 2022 after she arrived home from the appointment her underwear stuck to the affected area because of the blood.The area then seemed worse.On (b)(6) 2022, her abrasions were not getting better and were worse.On (b)(6) 2022, her abrasion sores and application site pain were a little better.The area looked raw and was still very sore.She continued to apply bacitracin ointment.As of (b)(6) 2022, the consumer had not had a follow up appointment, but she thought she might schedule a virtual appointment.No additional information was provided.

Manufacturer Narrative

Additional 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.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 3016050930-2022-00008 to explain the prior submission.The original submission on 20-may-2022 with date of awareness of 26-apr-2022 was submitted within the 30 day time period with an incorrect fei number.On 15-aug-2022, 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 3016050930-2022-00008.

Event Description

On 26-apr-2022, a spontaneous report from the united states was received regarding a 37-year-old female who used welly bravery badges space adhesive bandages.Medical history included a cancer diagnosis and a full hysterectomy (on (b)(6) 2022) with staples on her belly from surgery.Allergies included latex, perfumes, gain laundry detergent, and to prescriptions (not further specified).On (b)(6) 2022, she was discharged from the hospital and applied one welly bravery badges space adhesive bandage to the area where the hysterectomy surgery had been performed.On (b)(6) 2022, she applied a welly bravery badges space adhesive bandage.Upon removing the bandage the next morning, it ripped her skin off and it began to bleed.She immediately soaked up the blood.Once the blood stopped, she cleaned the area and applied bacitracin.She then applied gauze to the area with paper tape.The area was very painful.The area hurt more than when the bandage ripped off her skin.On (b)(6) 2022, she had a doctor appointment.Her doctor told her to completely discontinue the bandage, to continue to apply bacitracin, and keep it uncovered without a bandage or gauze of any kind.On (b)(6) 2022 after she arrived home from the appointment her underwear stuck to the affected area because of the blood.The area then seemed worse.On (b)(6) 2022, her abrasions were not getting better and were worse.On (b)(6) 2022, her abrasion sores and application site pain were a little better.The area looked raw and was still very sore.She continued to apply bacitracin ointment.As of (b)(6) 2022, the consumer had not had a follow up appointment, but she thought she might schedule a virtual appointment.No additional information was provided.

• Brand Name: WELLY BRAVERY BADGES SPACE ADHESIVE BANDAGE
• 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: jake schultz ; 30 s. 9th street, 7th floor; minneapolis, MN 55402 ; 6127153303
• MDR Report Key: 15263420
• MDR Text Key: 298283888
• Report Number: 3016050930-2022-00008
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WLY1061
• Device Lot Number: 21006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female