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

Model Number ULTIMATE

Device Problems Break (1069); Product Quality Problem (1506); Material Twisted/Bent (2981)

Patient Problem Laceration(s) (1946)

Event Date 09/07/2019

Event Type  Injury  

Event Description

The clip on the malem bedwetting alarm opened up at night when daughter was fast asleep.The clip bent outward and broke.Onside the clip is a metal strip with very sharp edges.The clip poked into my daughter's thighs and when she moved, it cut her.We are in shock from this poor quality workmanship and sorry that we used this product.There was a lot of blood as the result of the cut and many blood stains on the bed.Disappointed with quality and safety of the malem alarm.Fda safety report id# (b)(4).

• Brand Name: BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.
• MDR Report Key: 8991354
• MDR Text Key: 157819591
• Report Number: MW5089685
• 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: 09/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMATE
• Device Catalogue Number: PRO
• Device Lot Number: BLUE COLOR ALARM
• 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