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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION TR BAND CLAMP, VASCULAR

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TERUMO MEDICAL CORPORATION TR BAND CLAMP, VASCULAR Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pseudoaneurysm (2605); Swelling/ Edema (4577)
Event Date 03/21/2022
Event Type  Injury  
Event Description
The user facility reported that they discovered a hematoma above the tr band in recovery. The patient arrived in recovery with a hematoma. They applied a bp cuff just above the hematoma. Swollen from thumb to mid-forearm. They removed tr band to do an ultrasound. Duplex showed pseudo-aneurysm and the patient went to the operating room (or) for vascular surgery. The patient was discharged. Post procedure hematoma and surgical intervention required. Additional information was received on 30 mar 2022: the procedure performed prior to using the tr band was a left/right heart catheterization. There were 11ml's of air injected into the tr band when it was applied. There was no noticeable damage to the device. The patient was in stable condition. Surgical intervention was successful.
 
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. The actual device was not returned for evaluation. The investigation is currently ongoing. A follow-up report will be submitted once the investigation is complete. A review of the device history record of the product code/lot# combination was conducted with no findings.
 
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Brand NameTR BAND
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
elkton MD 21921
Manufacturer (Section G)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
elkton MD 21921
Manufacturer Contact
stephanie handy
950 elkton blvd.
elkton, MD 21921
9499890491
MDR Report Key14163443
MDR Text Key289878193
Report Number1118880-2022-00023
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberTRB24-REG
Device Lot Number0000102801
Was Device Available for Evaluation? No
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/20/2022 Patient Sequence Number: 1
Treatment
BP CUFF
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