MAUDE Adverse Event Report: COMPASS HEALTH BRANDS BED BUDDY HOT & COLD PACK

Model Number BBF1996-03

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

Device thrown away by consumer.

Event Description

Consumer called in and advised that her bed buddy that she used for a month exploded in the microwave.The product was thrown away.The consumer microwaved it in a 1,200 watt microwave for 60 seconds, then another 20 seconds.The consumer walked away to go to the fridge.The microwave has a turntable.

• Brand Name: BED BUDDY HOT & COLD PACK
• Type of Device: HOT & COLD PACK
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 11 morris dr.; suite 111; dartmouth, nova scotia B3B 1 M2; CA B3B 1M2
• Manufacturer (Section G): COMPASS HEALTH BRANDS; 11 morris dr.; suite 111; dartmouth, nova scotia B3B 1 M2; CA B3B 1M2
• Manufacturer Contact: kaycee nichols ; 6753 engle road; middleburg heights, OH 44130 ; 8009471728
• MDR Report Key: 5657941
• MDR Text Key: 45922513
• Report Number: 9681423-2016-00003
• Device Sequence Number: 1
• Product Code: IME
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BBF1996-03
• Device Catalogue Number: BBF1996-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2016
• Date Report to Manufacturer: 05/16/2016
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1