MAUDE Adverse Event Report: NAKEN BEDWETTUBG ABD EBYRESUS AKARN

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 11/04/2015

Event Type  Injury  

Event Description

Inserted batteries in the product and put it on my son.The alarm was placed near my son's neck.A few hours later, at night, while he slept, he screamed and cried in pain.The alarm exploded and batteries leaked into my son's neck leaving permanent scars on him.If we had not gone on time, i think it would have made a hole in his neck.Mfr reported as the bedwetting store.

• Brand Name: NAKEN BEDWETTUBG ABD EBYRESUS AKARN
• Type of Device: NAKEN BEDWETTUBG ABD EBYRESUS AKARN
• MDR Report Key: 5220567
• MDR Text Key: 31036835
• Report Number: MW5057817
• Device Sequence Number: 1
• Product Code: KPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 6 YR
• Patient Weight: 25