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

Catalog Number M

Device Problems Thermal Decomposition of Device (1071); Leak/Splash (1354); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 06/22/2019

Event Type  Injury  

Event Description

Horrible product.Couldn' t turn off, ended up burning my son.He was hiding under the bed crying while the alarm kept burning him.He was crying loud and that ended up waking everyone in the middle of the night.Alarm is defective.Not working now.The internal electronics are burnt and you can see battery leaked inside.Battery door wont close as heat has changed the shape of the plastic.Fda safety report id # (b)(4).

• Brand Name: ULTIMATE MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL LTD.; GB
• MDR Report Key: 8735483
• MDR Text Key: 149390340
• Report Number: MW5087631
• 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: 06/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M
• Device Lot Number: 042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2019
• 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