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

Model Number ULTIMATE BEDWETTING ALARM

Device Problems Leak/Splash (1354); Overheating of Device (1437); Material Rupture (1546)

Patient Problems Erythema (1840); Burn, Thermal (2530)

Event Date 09/03/2019

Event Type  Injury  

Event Description

Daughter was asleep and alarm burst and hurt her.She has burn marks and red patches now.Alarm not working.Battery leaked on skin and it was hot.She removed it, a little later which caused injury.If even more late, would be very dangerous.Alarm is dangerous and no good.Fda safety report id # (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8981301
• MDR Text Key: 157360960
• Report Number: MW5089642
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE BEDWETTING ALARM
• Device Lot Number: M042
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR