MalfunctionFMC
QUEEN DISPOSABLE NITRILE GLOVES
Received Apr 23, 2021 · Event occurred Apr 21, 2021
Report MW5100971 · MDR key 11723576
Device
Generic name
Patient Examination Glove
Manufacturer
Guangdong Junan Medical Technology Co., LtdModel number
ALL SIZESProduct problems
- Defective Device
- Therapeutic or Diagnostic Output Failure
Patient
Not reported
- Exposure to Body Fluids
- Chemical Exposure
- Exposure to Body Fluids
- Chemical Exposure
Narrative
Description of Event or Problem
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).