MAUDE Adverse Event Report: GUANGDONG JUNAN MEDICAL TECHNOLOGY CO., LTD QUEEN DISPOSABLE NITRILE GLOVES; PATIENT EXAMINATION GLOVE

Model Number ALL SIZES

Device Problems Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Exposure to Body Fluids (1745); Chemical Exposure (2570)

Event Date 04/21/2021

Event Type  malfunction  

Event Description

Queen nitrile gloves have a very high failure rate and manufacturer intended use as "non-medical" yet they are our only exam gloves at (b)(6).I have repeatedly sustained exposure to pathogens, body fluids, feces, hazardous medications and hazardous chemicals due to failure of these gloves.Fda safety report id # (b)(4).

• Brand Name: QUEEN DISPOSABLE NITRILE GLOVES
• Type of Device: PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): GUANGDONG JUNAN MEDICAL TECHNOLOGY CO., LTD
• MDR Report Key: 11723576
• MDR Text Key: 247577552
• Report Number: MW5100971
• Device Sequence Number: 1
• Product Code: FMC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/21/2021

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
• Device Operator: Health Professional
• Device Model Number: ALL SIZES
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1