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

Model Number ULTIMATE ALARM

Device Problems Overheating of Device (1437); Electrical Shorting (2926)

Patient Problems Scarring (2061); Burn, Thermal (2530)

Event Date 05/04/2020

Event Type  Injury  

Event Description

Last week my son used the malem bedwetting alarm for the first time with disastrous results.The alarm was placed on him as the instructions said and he was sleeping when 45 minutes into his sleep, he had a urine accident.The alarm did not beep or vibrate to wake him up.Instead, the alarm short circuited and it heat up and got hot.The alarm burnt him and he suffered scars on his neck and chest.We rushed him to urgent care for treatment.They have taken the alarm and we have contacted the manufacturer (malem) with no response.Dangerous device.Fda safety report id # (b)(4).

• Brand Name: ENURESIS AND BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 10051389
• MDR Text Key: 191007666
• Report Number: MW5094467
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE ALARM
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 5 YR