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

Model Number M04

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437); Noise, Audible (3273)

Patient Problems Burn(s) (1757); Erythema (1840); Scarring (2061)

Event Date 12/17/2017

Event Type  malfunction  

Event Description

I purchased two of the malem ultimate bedwetting alarms for my (b)(6) year old twins.Both were set up last night on the boys and they were put to bed.I checked back on them 15 minutes later and then again 30 minutes later.One of the alarms seemed to operate ok, the other one was very hot and making a clicking sound.I pulled it out of his shirt and noticed that some of the battery had leaked out of the alarm onto his neck.I immediately woke up my sons and removed both alarms.The first one seemed ok, but the second one was indeed hotter than normal.The batteries had somehow leaked due to electrical problem i believe.The battery material has burnt my child in small spot on his neck and left a tiny red scar the size of a thumbnail.Both alarms were new and arrived 1 day prior to the incident.The batteries used were the ones that came with the alarm.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7133832
• MDR Text Key: 95497195
• Report Number: MW5074118
• 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: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 20