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

Device Problem Temperature Problem (3022)

Patient Problem Scarring (2061)

Event Date 09/25/2018

Event Type  Injury  

Event Description

Faulty and dangerous this malem bedwetting alarm has caused so much harm to my (b)(6) daughter that she has started wetting in the mornings as well.The alarm got so hot that it not only left a scar on her neck, but it has made her tremble with fear to use anything anymore.The mfr should be fined and all malem alarms should be out of the market, so no other child is harmed.

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 7990249
• MDR Text Key: 124669398
• Report Number: MW5080717
• 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: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR