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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EGNELL, INC.AMEDA EGNELL SUCTION PUMP

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EGNELL, INC. AMEDA EGNELL SUCTION PUMP   Back to Search Results
Model Number ESU MODEL 17 U
Device Problem Increase in suction
Event Date 05/28/1998
Event Type  Death   Patient Outcome  Death
Event Description

Infant death within 7 hours of delivery. Autopsy revealed scalp hematoma with brain injury consistent with complications from vaccum ectracter.

 
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Brand NameAMEDA EGNELL SUCTION PUMP
Type of DeviceSUCTION PUMP
Manufacturer (Section F)
EGNELL, INC.
412 park ave.
cary IL *
Manufacturer (Section D)
EGNELL, INC.
412 park ave.
cary IL *
Device Event Key170470
MDR Report Key175325
Event Key164786
Report Number175325
Device Sequence Number1
Product CodeHDB
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial,Invalid data
Report Date 06/24/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberESU MODEL 17 U
Device Catalogue NumberUNLISTED 153B 60HZ 1.4A
OTHER Device ID Number100-120B
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/25/1998
Distributor Facility Aware Date06/24/1998
Device Age11 yr
Event Location Hospital
Date Report TO Manufacturer06/25/1998
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

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