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

Model Number M043

Device Problems Vibration (1674); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2019

Event Type  Injury  

Event Description

The alarm is unusable as is.Inserted batteries and plugged in sensor and the alarm shakes gently and gets hot.I was holding it trying to figure out why it's vibrating.I removed the sensor and shaking stopped.Reinserted the sensor and shaking started.I tried to call the mfr with the sensor connected and to my surprise, the device got warmer and warmer until it was not possible to hold it in my hands.For my safety, i removed the sensor and repeated the same with different batteries.Same thing all over again.The issue is not with batteries, but with the device itself.Too hot to operate safely.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE BEDWETTING ALARM BY MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8636209
• MDR Text Key: 146100363
• Report Number: MW5086844
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M043
• Device Catalogue Number: ULTIMATE ALARM FOR BEDWETTING
• 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): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 23