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

Model Number M043

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Rash (2033); Electric Shock (2554)

Event Date 05/22/2019

Event Type  Injury  

Event Description

Although new, the alarm is giving my son shocks when he wets the bed.He did not realize it at first, but then as his bedwetting progressed over the week, he complained of rash on his skin when he was urinating.Unsure what the cause was.We gave him home treatment.One day, when he was asleep, he wet again but was slightly awake and he felt the shock.He told us and we tested the alarm with water and it gives a shock.The shock does not stop till the batteries are removed.The alarm has been returned to the mfr.Fda safety report id# (b)(4).

• Brand Name: MALEM ALARM
• Type of Device: ALARM, CONDITIONED, RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8655416
• MDR Text Key: 146672465
• Report Number: MW5087007
• 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: 05/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M043
• Device Catalogue Number: ULTIMATE
• Device Lot Number: BEDWETTING ALARM
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR