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

Model Number MALEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Skin Irritation (2076)

Event Date 11/19/2019

Event Type  Injury  

Event Description

There is something seriously wrong with the way this bedwetting alarm is working.We have used it for about 6 nights and my son has developed skin irritation where alarm is placed on the skin.Not the sensor part, but where the alarm is placed.This is not normal.The first night it was used, he had a small red patch, then the patch grew as the alarm was used and he was in pain.I stopped using the alarm and his skin irritation went away.Started using it again and the irritation came back.This is not normal and strange considering that it was used as directed.There is something in the product itself which is making it cause skin irritation.Could be a chemical or excess heat it is generating when used.Fda safety report id # (b)(4).

• Brand Name: BED WETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9383376
• MDR Text Key: 168285034
• Report Number: MW5091313
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MALEM
• Device Catalogue Number: MALEM BLUE
• 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): Other
• Patient Age: 4 YR