MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-15 for MULTI-ABSORBER 8003138 X5 manufactured by Ge Healthcare.
[1250565]
On numerous occasions the disposable 'sodasorb' container was defective due to cracked plastic on the container.
Patient Sequence No: 1, Text Type: D, B5
[1451209]
On numerous occasions the disposable 'sodasorb' container was defective due to cracked plastic on the container.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1550172 |
| MDR Report Key | 1550172 |
| Date Received | 2009-11-15 |
| Date of Report | 2009-11-15 |
| Date of Event | 2009-10-21 |
| Report Date | 2009-11-15 |
| Date Reported to FDA | 2009-11-15 |
| Date Added to Maude | 2009-12-03 |
| 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 | MULTI-ABSORBER |
| Generic Name | ABSORBER, DISPOSABLE |
| Product Code | CBL |
| Date Received | 2009-11-15 |
| Returned To Mfg | 2009-10-26 |
| Model Number | NA |
| Catalog Number | 8003138 X5 |
| Lot Number | 368069/436079/409079 |
| ID Number | * |
| Device Availability | R |
| 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 | 2009-11-15 |