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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 Leak (2946)
Patient Problem No Information (3190)
Event Date 02/19/2019
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 has not been 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 they used a tr band and inserted 17cc of air in the band for hemostasis. After the event the patient was taken to the recovery area by a rn. Upon arrival, the rn noticed that the tr band balloon was flat. There was no evidence of bleeding. A additional 10cc of air was inserted into the band. The rn reported that she waited at the bedside for 2 minutes and the air remained in the balloon. A second rn checked the air within 5 minutes of the other rn leaving and reported that the balloon was again empty. Again, no sign of bleeding so they just watched the site closely. There was no hematoma post procedure. The patient was in stable condition. Additional information was received february 20, 2019: the procedure performed was a left heart catheterization, which was successful. There was no health damage to the patient.
 
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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 Key8396585
MDR Text Key139190748
Report Number1118880-2019-00034
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
Type of Report Initial,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2019
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 Received03/25/2019
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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