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

Model Number 8 TONES

Device Problem Overheating of Device (1437)

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

Event Date 12/14/2019

Event Type  malfunction  

Event Description

Alarm will not operate and do nothing.Just gets hot with batteries.Remove batteries and cools down.Insert batteries and gets hot.Very strange but appears to be dangerous.Fda safety report id # (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 9490581
• MDR Text Key: 172228807
• Report Number: MW5091718
• 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: Unknown
• Type of Report: Initial
• Report Date: 12/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8 TONES
• Device Catalogue Number: ULTIMATE PRO
• Device Lot Number: GOLD COLOR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• 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 Age: 8 YR