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Adverse Event Report

BAXTHER HEALTHCARE SURGICAL GROUP BLOOD PRESSURE CUFF   back to search results
Catalog Number 30504-013
Patient Outcome  Other;
Event Description

The bp cuff was unable to maintain pressure due to leaks from "mfg defect?".

 
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Brand NameBLOOD PRESSURE CUFF
Type of DeviceBLOOD PRESSURE CUFF
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BAXTHER HEALTHCARE SURGICAL GROUP
1430 waukegan rd
mcgaw park IL 60085
Device Event Key68460
MDR Report Key68478
Event Key64367
Report NumberMW1010712
Device Sequence Number1
Product CodeDXQ
Report Source Voluntary
Report Date 02/11/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number30504-013
Device LOT Number6D252770
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 30, 2009

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