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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEMACLEAR HEMACLEAR / 40 YELLOW ELASTIC TOURNIQUET

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HEMACLEAR HEMACLEAR / 40 YELLOW ELASTIC TOURNIQUET Back to Search Results
Model Number PRH 040 YE 01A
Event Date 09/29/2011
Event Type  Injury  
Event Description

Problem is severe pain with hemaclear tourniquet size yellow. Pt has end stage renal disease and was receiving hemodialysis via a right arm arteriovenous fistula. His fistula had malfunctioned because of an aneurysm. He was undergoing surgical repair with local anesthesia with iv sedation. The arm was measured and the yellow hemaclear tourniquet selected. Local anesthesia of 1% lidocaine was given and sedation with versed and fentanyl was given. After application of the tourniquet to the right forearm the pt complained of severe pain in the area of the elastic tourniquet ring. The tourniquet was cut off and the pain quit. A pneumatic tourniquet 18 inches was applied and the arm re-exsanguinated and then the tourniquet inflated to 250 mm hg pressure. There were no further problems during the operation.

 
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Brand NameHEMACLEAR / 40 YELLOW
Type of DeviceELASTIC TOURNIQUET
Manufacturer (Section D)
HEMACLEAR
MDR Report Key2276033
Report NumberMW5022457
Device Sequence Number1
Product CodeGAX
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/29/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/01/2014
Device MODEL NumberPRH 040 YE 01A
Device LOT NumberNZ-0611-08
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/29/2011
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 09/29/2011 Patient Sequence Number: 1
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