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

Model Number ULTIMATE PRO BEDWETTING ALARM

Device Problems Break (1069); Product Quality Problem (1506)

Patient Problem Injury (2348)

Event Date 12/16/2019

Event Type  malfunction  

Event Description

While inserting the sensor into the underwear, i had to lift (raise) the lever.When i did that, the lever broke.I barely used any force.In fact it was simple raise.The lever broke and a sharp piece of metal cut my fingers.I noticed that there were two flat metal plates inside which were exposed on the outside and these cut me pretty badly.I had to get first aid and a tetanus shot.Poor quality product.Fda safety report id # (b)(4).

• Brand Name: ULTIMATE PRO BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 9495086
• MDR Text Key: 172404666
• Report Number: MW5091752
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTIMATE PRO BEDWETTING ALARM
• Device Catalogue Number: GOLD 8 TONE
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR