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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 Unintended Deflation (4061)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2020
Event Type  malfunction  
Manufacturer Narrative
Patient identifier: requested, not provided, age & date of birth: requested, not provided, patient sex: requested, not provided, weight: requested, not provided, ethnicity: requested, not provided, race: requested, not provided, implanted date: device was not implanted, explanted date: device was not explanted, occupation: lead tech. 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.
 
Event Description
The user facility reported that the involved tr band was used during the procedure. The tr band would not inflate correctly. The balloon when inflated kept deflating; would not stay inflated. There was no patient injury, medical/surgical intervention required. The patient's condition was good. The procedure outcome was good.
 
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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
theresa mussaw
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key11064829
MDR Text Key225076142
Report Number1118880-2020-00342
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberTRB24-REG
Device Lot NumberYF07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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