MAUDE Adverse Event Report: DALE MEDICAL PRODUCTS, INC. DALE BENDABLE ARMBOARD; SPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL, STERILE

Model Number 650

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/11/2021

Event Type  Injury  

Event Description

The middle-aged patient was having an mri abdominal scan.Towards the end of the imaging exam, the patient squeezed the hand-held alarm ball and stated that his hand was burning.The patient was removed from the mr bore.The patient stated it was his right hand that was burning.The patient had an mri conditional arm board on his wrist.Upon taking the arm board off, the patient¿s skin was red, but he had no visible blistering at this time.An ice pack was applied and the patient's nurse, who escorted him to the study, was informed of the concern for a burn.The nurse assessed the patient and said she would reassess the area when the patient was back on the floor.

• Brand Name: DALE BENDABLE ARMBOARD
• Type of Device: SPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL, STERILE
• Manufacturer (Section D): DALE MEDICAL PRODUCTS, INC.; 40 kenwood circle suite 7; franklin, MA 02038
• MDR Report Key: 11541235
• MDR Text Key: 241429860
• Report Number: 11541235
• Device Sequence Number: 1
• Product Code: FYH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 650
• Device Catalogue Number: 650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18250 DA
• Patient Weight: 100