MAUDE Adverse Event Report: GUIZHOU CHIENYEH PHARMACEUTICAL PACKAGING CO.,LTD; ACCESSORY, SURGICAL APPAREL

Catalog Number 2020019

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 08/13/2020

Event Type  malfunction  

Event Description

Ear loops are disconnected when mask taken from box, or loops break the first time staff remove mask.

• Type of Device: ACCESSORY, SURGICAL APPAREL
• Manufacturer (Section D): GUIZHOU CHIENYEH PHARMACEUTICAL PACKAGING CO.,LTD; 1441 broadway,suite 5041,new york,ny 10018; manhattan NY 10018
• MDR Report Key: 10634847
• MDR Text Key: 210002312
• Report Number: 10634847
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2020019
• Device Lot Number: 2020019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1