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

Model Number M042

Device Problem Overheating of Device (1437)

Patient Problems Skin Irritation (2076); Burn, Thermal (2530)

Event Date 04/25/2019

Event Type  malfunction  

Event Description

The bedwetting device is too hot to operate correctly and safely.Within a few mins of setting it up, my son complains of it irritating his skin.I can validate this as it's also doing this with different batteries.My fingertips were mildly burnt from holding the device.It is not possible for this to be as is.Have returned it to the mfr where i purchased it.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING DEVICE
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8565726
• MDR Text Key: 143584475
• Report Number: MW5086280
• 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: 04/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M042
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR