MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT CUSTOM TOUCH

Model Number 812

Device Problems Bent (1059); Break (1069); Thermal Decomposition of Device (1071); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Event Description

Customer stated that "the heating pad burnt her bed and covers." product was returned for investigation.An investigation was done into the customers complaint of the product, and the inspector found that the customer had been misusing the product.The cord was twisted, the pad was bunched with bent and broken leads, and the pad was stained.The pad appeared to of been laid on while being in use.Ifu states "do not sit on, lie on, or crush pad." ifu states "loop cord loosely when storing.Tight wrapping may damage cord and internal parts." based on the bce review of feedbacks, bce did not observe a similar issue within the lot.

• Brand Name: CUSTOM TOUCH
• Type of Device: CUSTOM TOUCH
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 s reed rd; fremont IN 46737
• Manufacturer Contact: uday bahal
• MDR Report Key: 6871226
• MDR Text Key: 86605447
• Report Number: 1832415-2017-04707
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2015

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?: No
• Device Operator: No Information
• Device Model Number: 812
• Device Lot Number: 8123814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other