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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELLY HEALTH PBC WELLY BRAVERY BADGES; TAPE AND BANDAGE, ADHESIVE
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WELLY HEALTH PBC WELLY BRAVERY BADGES; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)
Event Date 04/24/2022
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 26-year-old male who used a welly bravery badges bandage.Medical history included a pimple or ingrown hair on the right bicep.Concomitant products were not provided.On (b)(6) 2022, the consumer topically applied a welly bravery badges bandage to his right bicep for a pimple or ingrown hair.On the morning of (b)(6) 2022, after he removed the bandage, he developed redness, itchiness, and bumpy skin in the area where the adhesive touched the skin.He applied neosporin and washed the area with soap and water.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.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 3016050930-2022-00009 to explain the prior submission.The original submission on 20-may-2022 with date of awareness of 30-apr-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 3016050930-2022-00009.
 
Event Description
On 30-apr-2022, a spontaneous report from the united states was received regarding a 26-year-old male who used a welly bravery badges bandage.Medical history included a pimple or ingrown hair on the right bicep.Concomitant products were not provided.On (b)(6) 2022, the consumer topically applied a welly bravery badges bandage to his right bicep for a pimple or ingrown hair.On the morning of (b)(6) 2022, after he removed the bandage, he developed redness, itchiness, and bumpy skin in the area where the adhesive touched the skin.He applied neosporin and washed the area with soap and water.No additional information was provided.
 
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Brand Name
WELLY BRAVERY BADGES
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 Key15263421
MDR Text Key298283636
Report Number3016050930-2022-00009
Device Sequence Number1
Product Code KGX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received08/20/2022
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 Received08/15/2022
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 Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age26 YR
Patient SexMale
Patient Weight82 KG
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