MAUDE Adverse Event Report: F&W INC DR. FAMILY; ACCESSORY, SURGICAL APPAREL

Model Number MODEL: 175MMX95MM

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Date 07/29/2020

Event Type  malfunction  

Event Description

Reported incidents of these masks' ear loops breaking while staff are wearing or the metal part of the mask becomes dislodged and pokes the face of the healthcare provider.

• Brand Name: DR. FAMILY
• Type of Device: ACCESSORY, SURGICAL APPAREL
• Manufacturer (Section D): F&W INC; 765 eastbury ave.; covina CA 91723
• MDR Report Key: 10459111
• MDR Text Key: 204543717
• Report Number: 10459111
• Device Sequence Number: 1
• Product Code: LYU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2020,08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MODEL: 175MMX95MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1