MAUDE Adverse Event Report: OWENS & MINOR DISTRIBUTION, INC. MEDICHOICE INSTANT WARM COMPRESS; PACK, HOT OR COLD, REUSABLE

Lot Number 24818-2

Device Problem Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

Inconsistently performing- some too hot while others are too cold.Packaging states up to 115 degrees.Feels much warmer at times than this.Opened box on unit and has no sleeves even though box states "with sleeve." other boxes have sleeves, signage being placed to use with sleeve or in pillowcase.

• Brand Name: MEDICHOICE INSTANT WARM COMPRESS
• Type of Device: PACK, HOT OR COLD, REUSABLE
• Manufacturer (Section D): OWENS & MINOR DISTRIBUTION, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 8416164
• MDR Text Key: 138663725
• Report Number: 8416164
• Device Sequence Number: 1
• Product Code: IME
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 24818-2
• 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: 02/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1