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

Model Number ULTIMATE

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Laceration(s) (1946)

Event Date 08/22/2019

Event Type  Injury  

Event Description

The clip sensor for the enuresis alarm just snapped right out of the wire and the two little metal pieces came out and cut my son's skin on the stomach.The metal pieces were cut deep in his stomach.It happened because the wire got entangled in his arm at night and the sensor was stuck to the underwear.But the metal pieces should not have come out and cut him.It¿s a faulty design.Fda safety report id # (b)(4).

• Brand Name: MALEM MEDICAL BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8936167
• MDR Text Key: 155935243
• Report Number: MW5089361
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE
• Device Catalogue Number: M042
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR