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

Model Number BEDWETTING ALARM

Device Problems Device Alarm System (1012); Leak/Splash (1354); Overheating of Device (1437)

Patient Problems Pain (1994); Sleep Dysfunction (2517); Burn, Thermal (2530)

Event Date 05/27/2019

Event Type  Injury  

Event Description

The complaint is related to a refurbished bedwetting alarm which was purchased by the seller on (b)(6).The seller claimed that the alarm has been used but restored to factory conditions.However the alarm is defective.When i put in on my son, he went to bed and then 30 mins later was crying in pain.The alarm was hot like an iron rod and it had rubbed and burnt him.His neck was red.He removed the alarm and it had battery leaking from it from the heat.Now they won't take it back or even return messages.He is in shock and is unable to sleep at night.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8671141
• MDR Text Key: 147226040
• Report Number: MW5087114
• 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: 05/30/2019

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: BEDWETTING ALARM
• Device Lot Number: M-042
• 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: 3 YR