CARD,LOAD RECORD,STERILIZATION
Received Jun 20, 2023 · Event occurred May 23, 2023
Report 1417592-2023-00253 · MDR key 17163191
Device
Generic name
Card,load Record,sterilization
Manufacturer
Medline Industries LpCatalog number
MDS200600
Lot number
230201
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Unknown
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED AN INFECTION. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THE SAMPLE WAS REQUESTED TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
REPORTED INFECTION DUE TO STERILIZATION INDICATOR
Additional Manufacturer Narrative
CORRECTED PRODUCT INFORMATION TO MDS200600.
Additional Manufacturer Narrative
UPDATED WITH INFORMATION GATHERED DUE TO SAMPLE BEING RETURNED. LOT NUMBER AND SAMPLE INFORMATION WAS UPDATED.