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

Device Problems Break (1069); Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 06/02/2020

Event Type  Injury  

Event Description

Patient was brought in at night.Cause of injury was an exploding enuresis alarm.Alarm was placed near patient's neck and it exploded from excess heat.Alarm battery leaked on patient's skin further causing pain and discomfort.Device was purchased new and no fault of parents or child.Used as directed.Cause of failure is the device itself.We have returned the device back to parents and are reporting this issue on parents behalf.Fda safety report id# (b)(4).

• Brand Name: MALEM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD. ; lowdham, nottingham ; UK
• MDR Report Key: 10162811
• MDR Text Key: 195716772
• Report Number: MW5095029
• 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 Practitioner
• Type of Report: Initial
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 7 YR