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

Catalog Number NUMBER 43

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 05/14/2019

Event Type  malfunction  

Event Description

Purchased and received a new malem alarm.Set it up at night and son went to bed.He came to us 3 hours later and complained that when he wet the bed, the alarm shocked him in his genitals.The alarm was removed at the time.I gently put some water in my hand and inserted the sensor and indeed i felt a gentle shock on my hand.That is scary.My son was wearing it at night and he was soaking in urine and he had to endure an electrical shock for over 2 minutes.The alarm has some safety issues associated with it.So we stopped using it and have gone back to medications.Fda safety report # (b)(4).

• Brand Name: ULTIMATE ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE, ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8645897
• MDR Text Key: 146360417
• Report Number: MW5086917
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: NUMBER 43
• Device Lot Number: M
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR