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U.S. Department of Health and Human Services

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

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3M COMPANY 3M N95 MASK MASK, SURGICAL Back to Search Results
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).

 
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Brand Name3M N95 MASK
Type of DeviceMASK, SURGICAL
Manufacturer (Section D)
3M COMPANY
MDR Report Key10983210
MDR Text Key220979609
Report NumberMW5098290
Device Sequence Number1
Product Code FXX
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/12/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/09/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1860S
Device LOT Number210190
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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