MAUDE Adverse Event Report: STRYKER STRYKJER LOW BOY BED

Model Number FL23SE

Device Problem Break (1069)

Patient Problem Skin Tears (2516)

Event Date 12/25/2014

Event Type  malfunction  

Event Description

Pt had 3 minor cuts from the plastic piece broken off on the bed side rail.Plastic top of bed side rail broken off.

• Brand Name: STRYKJER LOW BOY BED
• Type of Device: BED
• Manufacturer (Section D): STRYKER; kalamazoo 49002
• MDR Report Key: 4438048
• MDR Text Key: 5383900
• Report Number: MW5040243
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FL23SE
• Device Catalogue Number: FL23SE
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 48