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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 Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Date 03/06/2019
Event Type  malfunction  
Manufacturer Narrative
Expiration date - requested but unknown due to lot number being unknown. Udi - requested but unknown due to lot number being unknown. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date - requested but unknown due to lot number being unknown. 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. The product lot number was unknown, which prevented a meaningful review of the device history record and complaint files.
 
Event Description
The user facility reported that the balloon on the tb band device would not inflate. Additional information was received march 11, 2019: the air bladder was detached.
 
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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
mark vornheder
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key8445781
MDR Text Key139821336
Report Number1118880-2019-00038
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 03/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberTRB24-REG
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 Received03/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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