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

Device Problems Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 08/29/2019

Event Type  Injury  

Event Description

Daughter was asleep and her hand got stuck in the sensor cable.It detached from her underwear and the top plastic part broken and there was a very sharp piece of metal exposed.This pierced her skin near her belly and lodged there.She was crying and in pain.I had to remove it and worried about tetanus, but the nurse said no need for a tetanus shot.I left the alarm with the nurse in the hosp.Fda safety report id# (b)(4).

• Brand Name: MALEM BEDWETTING ALARM
• Type of Device: ALARM, CONDITIONED RESPONSE ENURESIS
• Manufacturer (Section D): MALEM MEDICAL, LTD.
• MDR Report Key: 8965336
• MDR Text Key: 157038841
• Report Number: MW5089573
• 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
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR