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

Model Number MO48TEC

Device Problems Leak/Splash (1354); Overheating of Device (1437); Defective Component (2292)

Patient Problem Burn, Thermal (2530)

Event Date 02/20/2020

Event Type  Injury  

Event Description

Reporting adverse effect with the use of a malem bedwetting alarm.The alarm was used first time last night and it has malfunctioned.It overheated and burnt my son¿s skin where it was in contact.Although minor, the burns were scary and we are worried.Alarm batteries leaked from the underside and alarm itself smelled strange.Non-operational now.Son has red mark on skin from the burning alarm.Skin burns.Fda safety report id # (b)(4).Fda received date: 02/21/2020.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 9753347
• MDR Text Key: 181331318
• Report Number: MW5093269
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MO48TEC
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR