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

Model Number	1860
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During covid-19 recalls sent by 3m regarding n95 masks with selective lot numbers which were identified as counterfeit by the vendor.The situation is being addressed by the facility's supply chain per the normal recall process: inventory pulled and end user notification.Manufacturer response for mask, surgical, 3m¿ (per site reporter).Device has been returned for replacement with actual article.

• Brand Name: 3M
• Common Device Name: MASK, SURGICAL
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 11307580
• Report Number: 11307580
• Device Sequence Number: 934910
• Product Code: FXX
• UDI-Device Identifier: 08887719257398
• UDI-Public: 08887719257398
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2021
• Report Date (Section F): 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 1860
• Device Catalogue Number: 1860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/08/2021