MAUDE Adverse Event Report: MALEM ALARM CONDITIONED RESPONSE ENURESIS

Device Problems Leak/Splash (1354); Overheating of Device (1437); Noise, Audible (3273)

Patient Problem Burn(s) (1757)

Event Date 12/03/2017

Event Type  malfunction  

Event Description

We were using a different brand of bedwetting alarm and switched to malem when the previous one stopped working.The malem alarm was purchased directly off (b)(6) and we received it last week.The very first night of use, i noticed that when batteries were placed into the alarm unit, the alarm unit started making a strange ticking sound.I removed batteries and tried again with the same batteries and also with new batteries.The alarm kept ticking.I placed it on the side of the bed and when i came back after 30 mins, the alarm had stopped ticking.I picked it up and black matter slipped onto my hand.The batteries had exploded in the alarm and the batteries leaked out.My palm and fingers were burnt from the defect in this product.

• Brand Name: ALARM CONDITIONED RESPONSE ENURESIS
• Type of Device: ALARM CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM
• MDR Report Key: 7108910
• MDR Text Key: 94641141
• Report Number: MW5073920
• 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: 12/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 YR
• Patient Weight: 25