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

Model Number M042

Device Problems Circuit Failure (1089); Unintended Ejection (1234); Overheating of Device (1437)

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

Event Date 05/22/2019

Event Type  Injury  

Event Description

Complaining about a malem ultimate bedwetting alarm (model m042) which short circuited within 30 mins of connection and set up.Alarm seemed proper at first, however when sensor is inserted, alarm made small vibrations like a stuck part and 10 mins later got warm.Could feel heat on her body after 15 mins and in 20 mins, had to remove the alarm for heat.Removed sensor and reinserted and same thing.After 30 mins, alarm stopped vibrating.Noticed battery leak on alarm.Unusable because of excess heat and burnt components.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED, RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8658406
• MDR Text Key: 146826319
• Report Number: MW5087029
• 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: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model 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 Outcome(s): Required Intervention