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

Model Number M05S

Device Problems Leak/Splash (1354); Overheating of Device (1437)

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 11/27/2018

Event Type  Injury  

Event Description

Step son¿s malem alarm got hot and leaked out batteries.The alarm burnt his neck and he is in pain.Had to take him to the doctor this morning and was told to discontinue use and report incident.Alarm was purchased from bedwettingstore.Com website in new condition.Arrived on (b)(6) and used just for one day.

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8124990
• MDR Text Key: 129244235
• Report Number: MW5081776
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M05S
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR