MAUDE Adverse Event Report: SCHUREMED SKYTRON; STANDARD ARMBOARD

Model Number 2-010-07

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 12/31/2017

Event Type  malfunction  

Event Description

This is a resubmission of mdr 1825014-2018-00002.Original mdr submission was not submitted correctly.This is in response to medwatch (b)(4) submitted by (b)(6) hospital.The medwatch states that a patient was at (b)(6) hospital for a carpal tunnel release.At the completion of the procedure while removing the arm board.Anesthesiology was removing the arm board from the surgical table and cut himself on a piece of metal on the arm board.He immediately washed the area and treated.Biomed contacted regarding the arm board.The arm board has been pulled from service and reported to skytron.Skytron is in receipt of the arm board and has begun an investigation.The manufacturer has been contacted and has been provided details of the medwatch.

• Brand Name: SKYTRON
• Type of Device: STANDARD ARMBOARD
• Manufacturer (Section D): SCHUREMED; 452 randolph street; abington MA 02351
• MDR Report Key: 10884155
• MDR Text Key: 217711682
• Report Number: 1825014-2020-00017
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2-010-07
• Device Catalogue Number: 2-010-07
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2020
• Distributor Facility Aware Date: 01/30/2018
• Device Age: 33 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other