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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 Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
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. The actual device has been 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 tr band was not holding air as well as they are used to. The patient was stable, and the procedure outcome was good. Additional information was received on 02december2021: the procedure performed was a left heart catheterization. Hemostasis was achieved with the tr band. There did not appear to be any damage to the tr band.
 
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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
mary o'neill
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key13095606
MDR Text Key284868986
Report Number1118880-2021-00217
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
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 Number0000054515
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2021
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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