CARDINAL HEALTH PERSONAL CLEANSING CLOTH, NON-FLUSHABLE, SCE
Received Feb 20, 2018 · Event occurred Jan 26, 2018
Report 1423537-2018-00159 · MDR key 7282578
Device
Generic name
Patient Personal Hygiene Kit
Manufacturer
Yangzhou Perfect Daily ChemicalsModel number
552AWS64Catalog number
552AWS64
Lot number
N/A
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT NUMBER WAS NOT PROVIDED. YANGZHOU PERFECT DAILY CHEMICALS REVIEWED ALL THEIR INCOMING, IN-PROCESS AND FINAL INSPECTION RECORDS FOR THEIR LAST THREE LOT NUMBERS MANUFACTURED AND ALL MET SPECIFICATION. THEY REVIEWED THEIR SKIN IRRITATION TESTING REPORT AND SKIN SENSITIZATION TESTING REPORT AND BOTH MET SPECIFICATION. AS A SAMPLE WAS NOT AVAILABLE FOR FURTHER INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THERE IS NO ADDITIONAL ACTION TAKEN AT THIS TIME, BUT YANGZHOU PERFECT DAILY CHEMICALS WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.
Description of Event or Problem
THE END USER PATIENT REPORTED THAT WIPES ARE CAUSING SKIN IRRITATION.