MAUDE Adverse Event Report: MUNDI WESTPORT GROUP MUNDI UVC SANITIZER WRISTLET; DISINFECTANT, MEDICAL DEVICES

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hair Loss (1877); Unspecified Tissue Injury (4559)

Event Date 04/15/2021

Event Type  Injury  

Event Description

I purchased a mundi uvc sanitizing wristlet from the online website morning save (date of purchase march 31, 2021).It is provided that that the item is designed to sanitize small items such as keys, money or a cell phone.As indicated in the instructions, i placed my cell phone in the zipped-in wristlet for about a minute for each side.Thereafter this time, i had started experiencing a sore spot of my head and some slight hair damage and thought of the uvc exposure that could possibly be emitting from the wristlet.The wristlet did not come with a lot of instructions or warnings such as to whether one should be around the item when it is plugged in or how long to wait to remove the sanitized item.I think this could be considered a dangerous item if within less than 3 minutes of use that the product could cause bodily harm.The date of occurrence was around (b)(6) 2021 and i still have the item and instructions along with my online morning save account information.(sticker attached to packaging provides: produced for: mundi westport group, (b)(6); epa est.No.97754-chn-1, epa product reg.No.97754-dv-3).I filed a u.S.Consumer product safety complaint on (b)(6) 2021; however, it was indicated that the fda would be the appropriate contact.

• Brand Name: MUNDI UVC SANITIZER WRISTLET
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): MUNDI WESTPORT GROUP; p.o. box 2002; pine brook NJ 07058
• MDR Report Key: 11737262
• MDR Text Key: 248157430
• Report Number: MW5101018
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR