FDA Adverse Event
Injury
Summary report: N
CGH ALPHA 6000
MDR report key: 33796
·
Received March 27, 1996
Report
- Report Number
- 2243621-1996-00055
- Event Type
- Injury
- Date Received
- March 27, 1996
- Report Date
- March 25, 1996
- Manufacturer
- GAMBRO HEALTHCARE
- Product Code
- FJG
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- DC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FACILITY ALLEGED BLOOD LEAK DURING TREATMENT. NO PT INJURY REPORTED. EBL 150CC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CGH ALPHA 6000 | DIALYZER | FJG | GAMBRO HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |