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

Model Number M042

Device Problems Material Protrusion/Extrusion (2979); Scratched Material (3020)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 11/15/2019

Event Type  Injury  

Event Description

Daughter was sleeping with the alarm.It was being used for the first time.She moved in bed and the sensor got dislodged from her underwear.It moved up and there are two really sharp metal extrusions that cut her in the belly while she was asleep.The extrusions are like needles and we did not notice them when we placed it there or would never have used the product.My daughter was cut and there was some blood on the bed and her clothes.The sensor clip had broken and it exposed the metallic extrusions.This is a case of dangerous product design.Fda safety report id# (b)(4).

• Brand Name: ULTIMATE ALARM FOR BEDWETTING
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 9354129
• MDR Text Key: 167580029
• Report Number: MW5091216
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M042
• Device Catalogue Number: PRO ALARM FOR BEDWETTING
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR