|
|
| Catalog Number 0121137 |
| Event Date 04/28/1990 |
|
Patient Outcome
Required Intervention;
|
|
Event Description
|
Facility alleges dialyzer blood leak ten minutes into treatment.
Ebl>250 cc's.
No transfusion.
No further complications reported.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | CGH IC-5L (PC/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 | 101051 |
|---|
| MDR Report Key | 102683 |
|---|
| Event Key | 96545 |
|---|
| Report Number | 102683 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | FJG |
|---|
| Report Source |
Distributor
|
|---|
| Reporter Occupation |
Invalid Data
|
| Type of Report
| Initial |
|---|
| Report Date |
12/22/1995 |
| 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 | 00502N11 |
|---|
| Was Device Available For Evaluation? |
Yes
|
|---|
| Is The Reporter A Health Professional? |
Yes
|
|---|
| Was the Report Sent to FDA? |
No
|
|---|
| Distributor Facility Aware Date | 12/18/1995 |
|---|
| 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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