SODASORB
Received Sep 19, 2022 · Event occurred Jan 1, 1901
Report 3012307300-2022-19589 · MDR key 15445142
Device
Generic name
Absorbent, Carbon-dioxide
Catalog number
008870
Lot number
UNKNOWN
Product problems
- Device Damaged Prior to Use
- Device Damaged Prior to Use
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE USED DUE TO THE CONTAINER WAS CRACKED. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTION WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT SAMPLE HAS BEEN PROVIDED AND THE INVESTIGATION COULD NOT CONFIRM WHETHER A QUALITY RELATED ISSUE HAS RESULTED IN THE CUSTOMER REPORTED PROBLEM. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).