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Adverse Event Report

ELIGIX, INC. B-CELL HDM CELL SEPARATION SYSTEM BIOLOGIC   back to search results
Patient Outcome  Hospitalization;
Event Description

Pt was seen in the clinic with acute shortness of breath, right pleuritic chest pain, and low oxygen saturation. Pt was admitted to the hosp and treated with antibiotics because they were thought to have pneumonia. Ct scan showed pulmonary embolism, and pt was given iv heparin. Pt was given lovenox today and is still an inpatient.

 
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Brand NameB-CELL HDM CELL SEPARATION SYSTEM
Type of DeviceBIOLOGIC
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
ELIGIX, INC.
200 boston ave
medford MA 02155
Device Event Key312152
MDR Report Key322695
Event Key303543
Report NumberMW1021459
Device Sequence Number1
Product CodeGKT
Report Source Voluntary
Report Date 03/23/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/23/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Was Device Available For Evaluation? No Answer Provided
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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