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

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problems Laceration(s) (1946); Blood Loss (2597)

Event Date 03/05/2020

Event Type  malfunction  

Event Description

Slip sensor which is used on underwear broke when child was sleeping and cut his leg.Exposed metal strips caused a lot of bleeding when he was sleeping.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL
• MDR Report Key: 9817907
• MDR Text Key: 183291256
• Report Number: MW5093651
• 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
• Type of Report: Initial
• Report Date: 03/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7 YR