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

Device Problems Fire (1245); Device Emits Odor (1425); Defective Component (2292)

Patient Problem Scarring (2061)

Event Date 11/30/2019

Event Type  Injury  

Event Description

Pt is female, (b)(6) who was sleeping with enuresis alarm.Alarm was connected correctly and was new.Alarm appears to have caught fire or malfunctioned.Result was child's skin was scarred at contact and is in shock.Treatment was not particularly needed as parents promptly removed enuresis alarm and delivered first aid.Enuresis alarm is non-functional and has batteries leaked.Smells of burning plastic.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9409967
• MDR Text Key: 169048033
• Report Number: MW5091393
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 6 YR