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

Device Problem Overheating of Device (1437)

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

Event Date 08/08/2019

Event Type  Injury  

Event Description

I purchased a malem bedwetting alarm for my son and it burnt him at his privates.It was the first time we used this alarm and it malfunctioned.There is something seriously wrong with this product it overheats.We had to visit the nearest hospital and have my son admitted for a couple of hours.He is still in pain.I have contacted the manufacturer but there is no reply.The fda should look to investigate the issue with the manufacturer.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: 8944608
• MDR Text Key: 156097548
• Report Number: MW5089418
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 YR