MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 155

Device Problems Bent (1059); Thermal Decomposition of Device (1071); Hole In Material (1293); Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Event Description

Customer stated "had on her back, sitting on the couch leaning against it.Husband smelt something burning.Just got up and unplugged the pad.Burnt a hole through the pad itself." product was returned for investigation.An investigation was done into the customers complaint, and the inspector found that the product had appeared to of been misused.The pad was bunched, the leads were bent and touching other leads, the heater wire and harness were bent and touching each other.This was caused by years of misuse of the pad.Ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds" the product was approx.6 years and 10 months old when the incident occurred.Customer did not seek out medical attention.Based on the bce review of feedbacks, bce did not observe a similar issue within the lot.

• Brand Name: THERMOPHORE
• Type of Device: THERMOPHORE
• Manufacturer (Section D): BATTLE CREEK EQUIPMENT; 702 s reed rd; fremont IN 46737
• Manufacturer Contact: uday bahal
• MDR Report Key: 7193892
• MDR Text Key: 97815028
• Report Number: 1832415-2017-08223
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 155
• Device Lot Number: 1553810
• Was the Report Sent to FDA?: No
• 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