MAUDE Adverse Event Report: SURGICAL MASK; MASK, SURGICAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Dyspnea (1816)

Event Date 03/05/2020

Event Type  Injury  

Event Description

Surgical masks, blue, yellow or orange shortness of breath in a reactive airway disease patient.Fda safety report id# (b)(4).

• Brand Name: SURGICAL MASK
• Type of Device: MASK, SURGICAL
• MDR Report Key: 10613541
• MDR Text Key: 209629194
• Report Number: MW5097002
• Device Sequence Number: 1
• Product Code: FXX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 87