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

Model Number M042

Device Problem Unintended Electrical Shock (4018)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 05/24/2019

Event Type  Injury  

Event Description

The device is seriously defective.My (b)(6) y/o son woke to this thing screaming.It scared the life out of him and he is still frightened of the shock which he received from the alarm.My other child had similar issues growing up and we used another brand of alarm which cured his bedwetting and it worked just fine.This particular malem alarm was defective from start.The first night of using the alarm and within one hour, my son wet the bed and the alarm triggered.It just so happened that he screamed and called for help.This is the first time i have ever heard him scream.I ran into his room and found him terrified.He said that he received shocks from the bedwetting alarm from where the sensor was connected to the underwear.He pulled the sensor and threw the alarm.We made him take a cold water shower and applied medicated cream to help relieve the pain.I tested the alarm and it gives strong shocks.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8758160
• MDR Text Key: 150123147
• Report Number: MW5087798
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M042
• Device Catalogue Number: ULTIMATE ALARM SERIES
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• 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): Required Intervention