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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 Gas/Air Leak (2946)
Patient Problem Hematoma (1884)
Event Date 05/04/2022
Event Type  Injury  
Event Description
The user facility reported that the involved tr band balloon was leaking. Additional information was received 10 may 2022: the air was leaking from the large and small balloon assembly. 15 ml's of air was injected into the tr band when it was applied. The tr band started to be deflated right away. Hemostasis was achieved by holding pressure and applying a new tr band. Estimated blood loss was less than 250cc's. There was no noticeable damage to the device. The patient was in stable condition. A very small hematoma formed. Additional information was received 11 may 2022: the hematoma was formed after the first tr band attempt.
 
Manufacturer Narrative
Ethnicity - requested, not provided. Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation: inventory control specialist. 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 Key14523581
MDR Text Key292966603
Report Number1118880-2022-00043
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00389701011349
UDI-Public00389701011349
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 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2022
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 Number0000133346
Was Device Available for Evaluation? No
Date Manufacturer Received06/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2021
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: 05/27/2022 Patient Sequence Number: 1
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