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

Model Number ULTIMATE PRO ALARM FOR BOYS

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2019

Event Type  Injury  

Event Description

I have waited to report the incident assuming it was a defective unit i received.My son is bedwetting and the logical choice was to purchase an alarm for treatment.Purchased the malem ultimate pro bedwetting alarm and started using it immediately.I am familiar how these devices work.The alarm did not function correctly from the time it was powered on.It got too hot to safely operate and the only way to cool it down was to remove batteries.I also smell something that felt like the alarm was burning from the inside.I called the company and they replaced it by sending me a replacement.This arrived and once again, the same issue.The batteries have been changed and the alarm operated as expected.The defect is in the product itself.This makes it too hot to hold in hands, let alone place on child's skin and smell is unbearable.It is like something burns within the product.Bad quality and not reliable.Cannot happen twice.Fda safety report id# (b)(4).

• Brand Name: MALEM ULTIMATE PRO BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8843397
• MDR Text Key: 153134586
• Report Number: MW5088543
• 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: Physician
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE PRO ALARM FOR BOYS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR