MAUDE Adverse Event Report: 3M COMPANY 3M N95 MASK; MASK, SURGICAL

Model Number 1860S

Device Problem Component Missing (2306)

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

Event Date 04/12/2020

Event Type  malfunction  

Event Description

A 3m small (1860s) n95 masks received from manufacturer defective, missing one of the 2 straps.Lot #210190.Fda safety report id # (b)(4).

• Brand Name: 3M N95 MASK
• Type of Device: MASK, SURGICAL
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 10983210
• MDR Text Key: 220979609
• Report Number: MW5098290
• 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
• Type of Report: Initial
• Report Date: 07/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1860S
• Device Lot Number: 210190
• 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