SODASORB LF CO2 ABSORBENT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-30 for SODASORB LF CO2 ABSORBENT * manufactured by Wr Grace & Company.

Event Text Entries

[20920732] Crna reported that containers of sodasorb lf (co2 absorbent) arrive with partial color change or substantial color change, indicating absorption of co2 from ambient air. Asborbent dust coming out of outer plastic wrap indicates presence of a pin hole in the outer plastic film wrap.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1245206
MDR Report Key1245206
Date Received2008-10-30
Date of Report2008-10-30
Date of Event2008-10-30
Report Date2008-10-30
Date Reported to FDA2008-10-30
Date Added to Maude2008-12-01
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSODASORB LF CO2 ABSORBENT
Generic NameABSORBER, CARBON DIOXIDE
Product CodeBSF
Date Received2008-10-30
Model Number*
Catalog Number*
Lot NumberCW05-P128-05
ID Number*
Device AvailabilityY
Device Age1 DY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key1298617
ManufacturerWR GRACE & COMPANY
Manufacturer Address6050 WEST 51ST ST CHICAGO IL 60638 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-10-30

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