MAUDE Adverse Event Report: BATTLE CREEK EQUIPMENT THERMOPHORE

Model Number 055

Device Problems Crack (1135); Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

"customer stated "feeling like needles poking her or shocking her.She lays on the heating pad." the product was returned for investigation.An investigation was done into the customers complaint, and the inspector found a minor crack in the case.The pad was tested by a quality control technician and the pad was heating and functioning properly.Customer admitted to laying on the pad and therefore, the customer was misusing the pad.The ifu states "do not sit on, lie on, or crush pad.Avoid sharp folds." 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: 7294494
• MDR Text Key: 100890441
• Report Number: 1832415-2017-08521
• 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: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 055
• Device Lot Number: 0553811
• 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