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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OHK MEDICAL DEVICES, INC HEMACLEAR NONPNEUMATIC TOURNIQUET

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OHK MEDICAL DEVICES, INC HEMACLEAR NONPNEUMATIC TOURNIQUET Back to Search Results
Model Number MEDIUM YELLOW
Event Type  Injury  
Event Description

The pt experienced approx 50cm2 avulsion of skin when the hemaclear tournequet was rolled over the pt's forearm. The pt presented with bleeding and a swollen hand and arm from a malfunctioning arteriovenous fistula for dialysis. The arm was measured and then hemaclear tournequet size yellow was rolled over the pt's hand and forearm to assist with hemostasis during the arteriovenous fistula ligation procedure. While the roll-on tournequet was being rolled over the forearm, the skin tore and approx 50cm2 was avulsed.

 
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Brand NameHEMACLEAR
Type of DeviceNONPNEUMATIC TOURNIQUET
Manufacturer (Section D)
OHK MEDICAL DEVICES, INC
haifia, il-z 3309 5
ISRAEL 33095
MDR Report Key2202226
Report NumberMW5021685
Device Sequence Number1
Product CodeGAX
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/05/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMEDIUM YELLOW
Device Catalogue NumberPRH-040-YE-01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 08/05/2011 Patient Sequence Number: 1
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