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

Device Problem Overheating of Device (1437)

Patient Problem Skin Irritation (2076)

Event Date 08/20/2019

Event Type  Injury  

Event Description

I purchased a malem bedwetting alarm from malem medical, (b)(4).The alarm reached me in a torn and tattered box.I contacted the mfr but there was no reply.I connected the alarm the next night on my(b)(6) y/o son.As soon as he wet the bed started crying.I woke up, ran to him and noticed that he had successfully managed to take out the alarm and sensor, and he told me that the alarm overheated.He had a red patch on his chest and neck.We rushed him to our family dr who treated him and surprised to know what happened.Our dr told us to inform the fda about this issue.Your dept needs to look into this issue and take corrective action immediately.I have contacted the mfr twice, however, they have gone silence with no response whatsoever.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: 8949530
• MDR Text Key: 156265307
• Report Number: MW5089452
• 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: 08/28/2019

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR