MAUDE Adverse Event Report: KIMBERLY-CLARK GLOBAL SALES, LLC KIMBERLY-CLARK® FLUIDSHIELD¿ PFR95¿ RESPIRATOR AND SURGICAL MASK; RESPIRATOR,SURGICAL

Model Number	46727
Medical Device Problem Codes	Material Too Soft/Flexible (4007); Device Fell (4014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Nursing staff report during donning kimberly clark n95 duckbill regular size mask the rubber band didn't hold it's elasticity causing the mask to fall from their face.This incident was able to be repeated with five masks from two different boxes.

• Brand Name: KIMBERLY-CLARK® FLUIDSHIELD¿ PFR95¿ RESPIRATOR AND SURGICAL MASK
• Common Device Name: RESPIRATOR,SURGICAL
• Manufacturer (Section D): KIMBERLY-CLARK GLOBAL SALES, LLC; 1400 holcomb bridge road; roswell GA 30076
• MDR Report Key: 12819415
• Report Number: 12819415
• Device Sequence Number: 4652732
• Product Code: MSH
• UDI-Device Identifier: 00036000467277
• UDI-Public: (01)00036000467277
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/21/2021
• Report Date (Section F): 10/21/2021

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: Health Professional
• Device Model Number: 46727
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/21/2021