MAUDE Adverse Event Report: MALEM MEDICAL UK MALEM ENURESIS ALARM; MALEM BEDWETTING ALARM

Model Number ALL MODELS

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); Protective Measures Problem (3015)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

This complaint is to report the complete line of malem bedwetting alarms and other products sold in usa exclusively by (b)(4).These children's products violate and fail several child safety requirements including marketing to children without correct age guidelines, absence of lot number, lack of risk assessment and small parts which can cause chocking.These products have mechanical, chemical and other safety concerns, which are out of conformity for marketing products to children without correct age recommendation/guidance.Absence of lot number (lack of traceability).Lack of due diligence regarding an adequate risk-assessment/hazard assessment (as required).Choking hazard for children due to small parts.(b)(4).

• Brand Name: MALEM ENURESIS ALARM
• Type of Device: MALEM BEDWETTING ALARM
• Manufacturer (Section D): MALEM MEDICAL UK; UK
• MDR Report Key: 5665979
• MDR Text Key: 45699580
• Report Number: MW5062367
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ALL MODELS
• Device Lot Number: NONE ON PACKAGE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening