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

Model Number M04

Device Problems Leak/Splash (1354); Noise, Audible (3273)

Patient Problems Erythema (1840); Scar Tissue (2060); Reaction (2414)

Event Date 11/25/2017

Event Type  No Answer Provided  

Event Description

My son was using a bedwetting alarm but it did not work well and after several attempts to stop his bedwetting, i purchased a malem alarm for him.The alarm was similar to the one we had used before and set up was identical.Being a more expensive product, i thought it would work better.The alarm was placed on my son's top part of the t-shirt and the sensor was clipped on his underwear.The minute i clipped the sensor into the malem alarm, the alarm started buzzing and hissing.After about 1-2 minutes, it stopped and that's when i left my son in his room.When i came in 20 minutes later to check on him, he was asleep but the alarm had leaked batteries out.The battery powder was black and it had leaked on to his t-shirt.A little bit seeped through his t-shirt and spread on his body.He has had an allergic reaction to the battery leak and his body has scars and red patches from this.I have discontinued use of the alarm.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 7078599
• MDR Text Key: 93738343
• Report Number: MW5073680
• 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: 11/29/2017

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?: No
• Device Operator: No Information
• Device Model Number: M04
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR
• Patient Weight: 17