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

Model Number M04

Device Problems Break (1069); Temperature Problem (3022)

Patient Problems Erythema (1840); Burn, Thermal (2530)

Event Date 01/22/2019

Event Type  Injury  

Event Description

Our daughter was sleeping like she normally does with her bedwetting alarm, she was injured at night from the device malfunctioning.She was using another brand ((b)(6)) before, but it broke so we purchased this new alarm to replace the (b)(6).We purchased it from (b)(6) and it was in new condition.The alarm has a fault which makes it get hot and injure the user.Our daughter was in bed barely for an hour before the accident happened.She had a clothing between her and the alarm, but it was not enough to protect her completely.She was not burnt but the large heat from the alarm has caused big red marks and patches on her neck.

• Brand Name: MALEM
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8286224
• MDR Text Key: 134560713
• Report Number: MW5083427
• 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: 01/25/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M04
• Device Catalogue Number: BLUE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR