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

Model Number M04SB

Device Problems Overheating of Device (1437); Defective Device (2588)

Patient Problem Burn, Thermal (2530)

Event Date 04/04/2019

Event Type  Injury  

Event Description

Son is only (b)(6) years old and was sleeping with enuresis alarm connected on his body.The alarm is defective.It was put on my son at 8 pm and upon checking in on son at 8:45pm, the alarm was stinking like i was burning from the inside.In 45 mins, the batteries have shorted inside the alarm and caused it to overheat.The heat was significant and left a big red scare on my son's shoulder area where the alarm was placed.The alarm is defective and i have returned it back to the mfr.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED, RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8503978
• MDR Text Key: 141745491
• Report Number: MW5085783
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M04SB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR