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

Model Number M05RB

Device Problem Leak/Splash (1354)

Patient Problems Erythema (1840); Scarring (2061)

Event Date 10/03/2018

Event Type  Injury  

Event Description

Our daughter was injured at night when she was asleep.The alarm (malem alarm) that was placed on her somehow malfunctioned and injured her when she was sleeping.This is not normal and not expected.We have been using this alarm for the last 4 days and it seemed to work fine.It did not alarm when it was supposed to, but it seemed operate to per instructions 2 nights ago, we did nothing different.We connected the alarm on our daughter's shirt and she went to bed.An hour later, she cried out loudly and we rushed to see that the malem device had become hot and scarred her skin.There were small red patches (several of them) from skin contact and at different places on the neck.The batteries also leaked out from the device and just spread out on her clothing.We were not sure what to do and as the combination of heat and battery acid seemed risky, we took her to emergency room for appropriate treatment.They are the ones who treated her, cleaned her and have encouraged us to report the incident on the website.I have also reached out to the company (malem (b)(4)) from where i purchased the alarm, but i am not getting any response as they continue to ignore me.

• Brand Name: MALEM ULTIMATE RECORDABLE BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7951700
• MDR Text Key: 123388578
• Report Number: MW5080424
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05RB
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 5 YR
• Patient Weight: 27