MAUDE Adverse Event Report: WELLY HEALTH PBC WELLY BRAVERY BADGES ICE CREAM ADHESIVE BANDAGES

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Date 06/08/2022

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.If any additional information that was not available for this initial med-watch is obtained from the patient, an additional med-watch will be filed as appropriate.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 3-year-old female who used a welly bravery badges ice cream adhesive bandage.On (b)(6) 2022, additional information was received from the fda (mw5110236).Medical history included prior use of welly health bandages without issue.Concomitant products included an unspecified multivitamin and probiotic.At approximately 7 pm on (b)(6) 2022, the consumer topically applied a welly bravery badges ice cream adhesive bandage to her arm.At approximately 6:30 pm on (b)(6) 2022, she pulled the bandage off.The bandage pulled some of the skin off on her arm.The area was about 0.25 by 0.25 inches in size.Her skin was torn and there were several small spots of blood.The patient's mother washed the raw area, applied neosporin, and put a bandage on the area.The mother thought the adhesive was too strong.As of (b)(6) 2022, her skin was slightly red but was healing nicely.No additional information was provided.

Event Description

On 08-jun-2022, a spontaneous report from the united states was received via email regarding a 3-year-old female who used a welly bravery badges ice cream adhesive bandage.On 21-jun-2022, additional information was received from the fda (mw5110236).Medical history included prior use of welly health bandages without issue.Concomitant products included an unspecified multivitamin and probiotic.At approximately 7 pm on (b)(6) 2022, the consumer topically applied a welly bravery badges ice cream adhesive bandage to her arm.At approximately 6:30 pm on (b)(6) 2022, she pulled the bandage off.The bandage pulled some of the skin off on her arm.The area was about 0.25 by 0.25 inches in size.Her skin was torn and there were several small spots of blood.The patient's mother washed the raw area, applied neosporin, and put a bandage on the area.The mother thought the adhesive was too strong.As of (b)(6) 2022, her skin was slightly red but was healing nicely.No additional information was provided.

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.If any additional information that was not available for this initial med-watch is obtained from the patient, an additional med-watch will be filed as appropriate.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 3016050930-2022-00011 to explain the prior submission.The original submission on 24-jun-2022 with date of awareness of 08-jun-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 3016050930-2022-00011.

• Brand Name: WELLY BRAVERY BADGES ICE CREAM ADHESIVE 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: 15263423
• MDR Text Key: 298283642
• Report Number: 3016050930-2022-00011
• 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: Other,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
• 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
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED MULTIVITAMIN; UNSPECIFIED MULTIVITAMIN; UNSPECIFIED PRIOBIOTIC; UNSPECIFIED PRIOBIOTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 14 KG