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

Model Number M042

Device Problems Leak/Splash (1354); Smoking (1585); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 05/20/2019

Event Type  Injury  

Event Description

Suffered a major scare last night.My son is diagnosed with bedwetting at night and used the malem alarm for the first time at night on him.The results were horrible.The user manual is hard to understand because it is generic for all models.I set it up and put my boy to bed.He woke up screaming after 20 mins.By the time i reached him, he was in tears screaming that he was burning.Removed the alarm which had somehow become so hot that it was unusable.The alarm was removed and it lay on the bed.After 20 more mins, the batteries leaked out from heat and the alarm had black smoke coming out.The alarm is defective and is responsible for this incident.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8636287
• MDR Text Key: 146104545
• Report Number: MW5086846
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Catalogue 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
• Patient Age: 4 YR