MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-03 for GE MULTI ABSORBER, DISPOSABLE REF # 8003138 * manufactured by Ge Healthcare.
[1512228]
The used sodasorb cannister had been placed into trash, which was being emptied. Our staff member's hand was scratched by the very sharp molded edges along the handle. This sharp edge appears to be "by design" as we saw the same thing on all cannisters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1561508 |
| MDR Report Key | 1561508 |
| Date Received | 2009-12-03 |
| Date of Report | 2009-12-03 |
| Date of Event | 2009-11-17 |
| Report Date | 2009-12-03 |
| Date Reported to FDA | 2009-12-03 |
| Date Added to Maude | 2009-12-17 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | GE MULTI ABSORBER, DISPOSABLE |
| Generic Name | ABSORBER |
| Product Code | BSF |
| Date Received | 2009-12-03 |
| Model Number | REF # 8003138 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 540 W. NORTHWEST HWY BARRINGTON IL 60010 US 60010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-03 |