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

Model Number 1860

Device Problems Nonstandard Device (1420); Appropriate Term/Code Not Available (3191)

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

Event Date 02/05/2021

Event Type  malfunction  

Event Description

Covid-19 recall sent by 3m regarding n95 masks with selective lot numbers which were identified as counterfeit product by the vendor.Situation is being addressed by the facility's supply chain per the normal recall process.Inventory pulled and end user notification.

• Brand Name: 3M N95 MASK
• Type of Device: MASK, SURGICAL
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 11321271
• MDR Text Key: 231618230
• Report Number: MW5099350
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/10/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• 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