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

Model Number PRO ULTIMATE

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 12/11/2019

Event Type  Injury  

Event Description

Three nights ago, my daughter used the malem bedwetting alarm for the first time and sent to bed only to be woken up by a very nasty and painful stinging on her body.She was able to promptly remove the alarm and come to me and tell me that the alarm was burning her.By the time i went to check on it, the batteries had leaked out and there were fumes coming out from the top of the alarm.Needless to say, the alarm is non-functional.In my past experience, this is likely from electrical malfunction and/or poor quality component coupled with absolutely no qc.There would be no reason for a device designed for use in sleep by children to malfunction and cause injuries.My daughter has a minor burn on her body which will heal, but the trauma is significant.We can't use another alarm at all.My emails to the mfr have not been returned.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 9491166
• MDR Text Key: 171986319
• Report Number: MW5091740
• 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: 12/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PRO ULTIMATE
• Device Catalogue Number: 8 TONE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 7 YR
• Patient Weight: 27