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

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.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: UNK TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8800511
• MDR Text Key: 151425954
• Report Number: 1118880-2019-00186
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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 Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK TR BAND
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention