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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION TR BAND RADIAL ARTERY COMPRESSION DEVICE CLAMP, VASCULAR

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TERUMO MEDICAL CORPORATION TR BAND RADIAL ARTERY COMPRESSION DEVICE CLAMP, VASCULAR Back to Search Results
Model Number TRB24-REG
Device Problem No Pressure (2994)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/18/2022
Event Type  malfunction  
Event Description
Radial artery compression device would not hold pressure. Unsure if bladder or valve related issue. Fda safety report id # (b)(4).
 
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Brand NameTR BAND RADIAL ARTERY COMPRESSION DEVICE
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
TERUMO MEDICAL CORPORATION
elkton MD 21921
MDR Report Key15079192
MDR Text Key296415302
Report NumberMW5111035
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTRB24-REG
Device Catalogue NumberTRB24-REG
Device Lot Number0000186470
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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