MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE; PACK, HOT OR COLD, DISPOSABLE

Model Number CWP954

Patient Problem Skin Burning Sensation (4540)

Event Date 11/16/2023

Event Type  malfunction  

Event Description

Hot pack activated and placed on lower back with towel between.Hot pack exploded/leaked and went through towel and onto skin resulting in tingling and burning.

• Brand Name: MEDICHOICE
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 8489 westside industrial dr.; jacksonville FL 32219
• MDR Report Key: 18418073
• MDR Text Key: 331591448
• Report Number: 18418073
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CWP954
• Device Catalogue Number: CWP954
• Device Lot Number: 2307RA54A1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1