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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacturer date: unknown due to unknown lot number.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 production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.
 
Event Description
The user facility reported that they had bleeding complications with a tr band device in the catheterization lab.
 
Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Since the sample was not available for evaluation, the complaint could not be confirmed.The exact root cause cannot be determined.The dhr could not be reviewed since no lot number was available.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
 
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Brand Name
TR BAND
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
elkton MD 21921
MDR Report Key12389696
MDR Text Key268931949
Report Number1118880-2021-00198
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K152525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberTRB24-REG
Was Device Available for Evaluation? No
Date Manufacturer Received10/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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