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

Device Problems Leak/Splash (1354); Overheating of Device (1437)

Patient Problems Erythema (1840); Irritation (1941); Pain (1994); Scarring (2061); Reaction (2414); Burn, Thermal (2530)

Event Date 12/12/2017

Event Type  Injury  

Event Description

My son has had an accident.The malem bedwetting alarm over-heated and the batteries leaked onto his skin causing irritation and scars.I took him to the hospital for treatment where he was for a few hours.There were red patches from the leak on his skin.The scars have healed a little bit but the pain is still there.I believe it is due to allergic reaction to the batteries.The alarm was not operating well since the time batteries were inserted into it.It just kept getting hot and hot and then gray material came out of the malem alarm.

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7154298
• MDR Text Key: 96125461
• Report Number: MW5074269
• 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: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• 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): Hospitalization; Required Intervention
• Patient Age: 4 YR
• Patient Weight: 42