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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION UNK TR BAND CLAMP, VASCULAR

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TERUMO MEDICAL CORPORATION UNK 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 Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Expiration date - unknown due to unknown catalog and lot number. Udi - unknown due to unknown catalog and lot number. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date - unknown due to unknown catalog and lot number. (b)(4). 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 they had an issue with a terumo tr band. Additional information was received on july 15, 2019. The patient had an iv under the tr band. The patient went to surgery; however, it is unknown what the issue was that caused the patient to go to surgery. The patient was reported to be stable post-surgery.
 
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Brand NameUNK TR 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 Key8800511
MDR Text Key151425954
Report Number1118880-2019-00186
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 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNK TR BAND
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 Received08/21/2019
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

Patient Treatment Data
Date Received: 07/17/2019 Patient Sequence Number: 1
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