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

Model Number ULTIMATE - M042

Device Problems Thermal Decomposition of Device (1071); Leak/Splash (1354); Temperature Problem (3022)

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

Event Date 05/28/2019

Event Type  Injury  

Event Description

Something is wrong with the bedwetting device.The alarm got hot when daughter was asleep.It was hot and she came to me complaining of burning.I checked and the alarm was stinking of burning plastic like something inside was burning.I removed the alarm and noticed that batteries were leaking out and then it stopped getting hot.Now it's not working as the inside has burnt out.Daughter has bright red patches from burns.Fda safety report id# (b)(4).

• Brand Name: ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8670658
• MDR Text Key: 147108084
• Report Number: MW5087106
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE - M042
• 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): Required Intervention
• Patient Age: 7 YR