MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE; GENERAL SURGERY TRAY

Model Number CWP954

Device Problem Explosion (4006)

Patient Problems Skin Discoloration (2074); Chemical Exposure (2570); Skin Inflammation/ Irritation (4545)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Patient was using heat packs for pain management.Per patient as reported to nursing leadership the heat pack exploded.Chemicals got on his skin creating some redness and irritation.The heat pack exploded to the extent of it being on his body, phone, bed, and bedside wall behind him.Patient was showered and made sure that all chemicals were off his skin.Redness controlled.No further redness observed.Have included clean supply where heat packs are stored.Not anywhere near heat source in supply room.Manufacturer response for pack, hot or cold, disposable, medichoice (per site reporter) [redacted date] materials management reported this patient safety issue to cardinal.

• Brand Name: MEDICHOICE
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood blvd.; mechanicsville VA 23116
• MDR Report Key: 16156754
• MDR Text Key: 307279327
• Report Number: 16156754
• Device Sequence Number: 1
• Product Code: LRO
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CWP954
• Device Lot Number: 22048454A2, 2205RA54B2
• 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: 12/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Hispanic