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

Model Number DARK BLUE

Device Problems Break (1069); Malposition of Device (2616)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Date 09/01/2019

Event Type  Injury  

Event Description

The clip that connects to the underwear broke as my daughter rolled over at night and exposed two sharp metal flat blades.As she moved, the cable cut pulled up and the sensor moved up towards her body.The sensor is running below shirt and as she moved more, the metal cut her stomach.She woke up crying and there was some blood (not much), like a cut from a knife.The sensor was lodged in her stomach at the time.I pulled it out.Never have we had such a scary experience with an electronic device.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE BEDWETTING ALARM (SELECTABLE)
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD
• MDR Report Key: 8965040
• MDR Text Key: 156789367
• Report Number: MW5089560
• 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: 09/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DARK BLUE
• 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): Other
• Patient Age: 6 YR