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

Model Number M05

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

Patient Problem Burn, Thermal (2530)

Event Date 01/23/2019

Event Type  Injury  

Event Description

The malem bedwetting alarm is not adequate for children¿s use.A new alarm was used only for an hour at night and it burnt my son.Something inside the alarm caused it to overheat.This seems very strange, considering it is operated by two simple batteries, but the amount of heat was significant to hurt my son when asleep.Also, the batteries leaked within the alarm making it useless to operate.We did not have wet hands or drop it.This was purchased new from the manufacturer and it has burnt my son.

• Brand Name: MALEM ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8290119
• MDR Text Key: 134853406
• Report Number: MW5083496
• 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: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: M05
• Device Lot Number: BLUE COLOR
• 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: 5 YR
• Patient Weight: 18