MAUDE Adverse Event Report: MALEM MEDICAL LTD. MALEM; ENURESIS ALARM

Model Number M048TEC

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Overheating of Device (1437)

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

Event Date 05/12/2018

Event Type  malfunction  

Event Description

Upon inserting batteries into the alarm, the device starts getting hot.After a few minutes, the device was so hot that i could not hold it in my hand.I placed it on the side with the batteries still in it.An hour later, the batteries exploded inside the alarm and leaked out of the counter top.I can't imagine what would have happened if this were placed on my daughter's body as per user directions.Dangerous device.

• Brand Name: MALEM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7518238
• MDR Text Key: 108508604
• Report Number: MW5077248
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/13/2018

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?: Yes
• Device Operator: No Information
• Device Model Number: M048TEC
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR