ALBA HEALTH
Received Jan 30, 2023
Report 3014527682-2023-00001 · MDR key 16263677
Device
Product problems
- Contamination
- Contamination
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED "MOLD ON STOCKINETTE." NO LOT, SAMPLE, OR PICTURE WAS PROVIDED BY COMPLAINANT. DATE OF EVENT WAS UNKNOWN AND NOT PROVIDED BY COMPLAINANT.
Additional Manufacturer Narrative
THE AFFECTED STOCKINETTE WAS CONTAINED IN A CONVENIENCE KIT MANUFACTURED BY ROI CPS, LLC. NO OTHER REPORTS HAVE BEEN RECEIVED RELATED TO CONTAMINATION ON OTHER STOCKINETTES USED IN THE PRODUCTION OF CONVENIENCE KITS. THE USER OF THE DEVICE/COMPLAINANT DID NOT PROVIDE ANY DETAILS RELATED TO THE EVENT. THIS MDR REPORT IS BEING FILED DUE TO THE UNKNOWN FACTORS OR DETAILS RELATED TO THE EVENT AND THE SOURCE OF THE ALLEGED CONTAMINATION IDENTIFIED AS "MOLD" BY THE USER.