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

Model Number M042

Device Problems Overheating of Device (1437); Defective Component (2292)

Patient Problems Burning Sensation (2146); Burn, Thermal (2530)

Event Date 06/15/2018

Event Type  No Answer Provided  

Event Description

We used another brand of bedwetting alarm before (ramsey coote) but did not have very good success.So we started using the malem ultimate alarm.The alarm is defective.It overheats when in put in batteries.This is not a battery related issue as the alarm gets hot with different battery brands as well.The hot alarm burnt my daughter's neck near her chin at night and she has a stinging like sensation.This alarm is defective and not safe.I will contact and return it back to the mfr.The alarm gets very hot and it is impossible to hold in the hand.

• Brand Name: MALEM ULTIMATE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 7619029
• MDR Text Key: 111863992
• Report Number: MW5077938
• Device Sequence Number: 1
• Product Code: KPN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• 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): Other
• Patient Age: 5 YR
• Patient Weight: 24