MAUDE Adverse Event Report: SAFESOURCE DIRECT MASK; MASK, SURGICAL

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/27/2023

Event Type  Injury  

Event Description

Bad products causing hives.Products are jokes or counterfeit.Bad materials.

• Brand Name: MASK
• Type of Device: MASK, SURGICAL
• Manufacturer (Section D): SAFESOURCE DIRECT
• MDR Report Key: 17870488
• MDR Text Key: 325010066
• Report Number: MW5146523
• Device Sequence Number: 1
• Product Code: FXX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization