|
Catalog Number 0121137 |
Event Date 08/27/1990 |
Patient Outcome
Required Intervention;
|
Event Description
|
Facility alleges dialyzer blood leak.
Ebl 200 cc.
No pt injury reported.
|
|
Search Alerts/Recalls
|
|
|
Brand Name | CGH IC-5L (PL/CU/1.1/L) |
Type of Device | DIALYZER |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
COBE LABORATORIES |
po box 101460 |
atlanta GA 30392 |
|
Manufacturer (Section D) |
COBE LABORATORIES |
po box 101460 |
atlanta GA 30392 |
|
Device Event Key | 100932 |
MDR Report Key | 102558 |
Event Key | 96427 |
Report Number | 102558 |
Device Sequence Number | 1 |
Product Code | FJG |
Report Source |
Distributor
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
02/05/1996 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 04/24/1996 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0121137 |
Device LOT Number | 0525N11 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 08/27/1990 |
Event Location |
Outpatient Treatment Facility
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
No Answer Provided
|
|
|
Database last updated on January 06, 2009
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