MAUDE Adverse Event Report: NEMSCHOFF 360-91BH SIDE CHAIR

Model Number 360-91BH

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 09/08/2016

Event Type  Injury  

Event Description

Psych-safe chair was used as a projectile and thrown by patient.Chair then shattered into 17 pieces, 12 were sharp and jagged wooden sticks.The patient then used the sticks to stab holes in the sheetrock, damaged the overhead lighting, and disrupt the sprinkler system.

• Brand Name: 360-91BH SIDE CHAIR
• Type of Device: CHAIR
• Manufacturer (Section D): NEMSCHOFF; sheboygan WI 53082
• MDR Report Key: 5955754
• MDR Text Key: 55018365
• Report Number: MW5064787
• Device Sequence Number: 1
• Product Code: INM
• 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: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 360-91BH
• Device Catalogue Number: PL9-12
• Device Lot Number: 160617-320635003
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR