MAUDE Adverse Event Report: HEBEI LICHE ZHUOGE NEW MATERIALS CO., LTD MYAIRSHIELD; DISINFECTANT, MEDICAL DEVICES

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

Event Type  Injury  

Event Description

After the first week of everyday wearing the badge myairshield became totally defected (the hole for lanyard was broken, the badge sides were unglued, the netting of the holes, where granules are seen, disappeared and granules just tipped out).It became dangerous because of chlorine dioxide granules spreading from the badge everywhere around.Fda safety report id # (b)(4).

• Brand Name: MYAIRSHIELD
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): HEBEI LICHE ZHUOGE NEW MATERIALS CO., LTD
• MDR Report Key: 10792408
• MDR Text Key: 215078747
• Report Number: MW5097663
• Device Sequence Number: 1
• Product Code: LRJ
• Reporter Country Code: UP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2020
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 58