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

Model Number ULTIMATE

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problems Choking (2464); Foreign Body In Patient (2687)

Event Date 06/05/2019

Event Type  malfunction  

Event Description

A (b)(6) child was using the malem alarm for bedwetting.Per parents description, child was playing with sensor and the clip opened and fell off.Child swallowed the clip and started to choke.Fortunately parents were able to retrieve plastic part from child's mouth on time.The clip fell off with no resistance.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD; nottingham ; UK
• MDR Report Key: 8699767
• MDR Text Key: 148151120
• Report Number: MW5087351
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ULTIMATE
• Device Catalogue Number: M04S - MAGENTA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR