MAUDE Adverse Event Report: KIMBERLY-CLARK GLOBAL SALES, LLC KIMBERLY-CLARK N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK; RESPIRATOR,SURGICAL

Model Number 46827

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

As reported by the cath lab manager, "we have consistently found that we are attempting to "don" these masks, the rubber straps break before we're able to stretch them over our heads.Have had staff members go thru multiples out of a single box before they'll find one that will go on without breaking." this concern has been raised by other departments within our hospital as well.

• Brand Name: KIMBERLY-CLARK N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK
• Type of Device: RESPIRATOR,SURGICAL
• Manufacturer (Section D): KIMBERLY-CLARK GLOBAL SALES, LLC; 1400 holcomb bridge road; roswell GA 30076
• MDR Report Key: 10487550
• MDR Text Key: 205490664
• Report Number: 10487550
• Device Sequence Number: 1
• Product Code: MSH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46827
• Device Catalogue Number: 46827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1