MAUDE Adverse Event Report: STRYKER STRYKER; STRYKER CRIB

Model Number FL 19F

Device Problems Break (1069); Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2016

Event Type  malfunction  

Event Description

A stryker crib has a broken protector shield around the lever to raise and or lower the side rail.This resulted in sharp edges being exposed to the operator of the crib.

• Brand Name: STRYKER
• Type of Device: STRYKER CRIB
• Manufacturer (Section D): STRYKER; kalamazoo MI 49002
• MDR Report Key: 5403642
• MDR Text Key: 37339279
• Report Number: MW5059822
• Device Sequence Number: 1
• Product Code: FMS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FL 19F
• Device Catalogue Number: FL 19-4410
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1