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 * manufactured by Wr Grace & Company.
[21287379]
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. Absorbent dust coming through bottom of plastic wrap indicates existence of one or more pin holes in plastic film wrap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1242823 |
| MDR Report Key | 1242823 |
| Date Received | 2008-10-30 |
| Date of Report | 2008-10-30 |
| Date of Event | 2008-10-30 |
| Report Date | 2008-10-30 |
| Date Reported to FDA | 2008-10-30 |
| Date Added to Maude | 2008-11-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SODASORB LF |
| Generic Name | ABSORBER, CARBON DIOXIDE |
| Product Code | BSF |
| Date Received | 2008-10-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | CV07-P128 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1296238 |
| Manufacturer | WR GRACE & COMPANY |
| Manufacturer Address | 6050 WEST 51ST ST CHICAGO IL 60638 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-30 |