MAUDE Adverse Event Report: STRYKER GLOBAL HEADQUARTERS STRYKER; STRYKER CRIB

Model Number FL 19H

Device Problems Break (1069); Scratched Material (3020)

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

Event Date 09/01/2015

Event Type  malfunction  

Event Description

We have a stryker crib that has a broken protector shield around the level 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 GLOBAL HEADQUARTERS; 2825 airview blvd.; kalamazoo MI 49002
• MDR Report Key: 5311003
• MDR Text Key: 33955278
• Report Number: MW5058581
• 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: Other
• Type of Report: Initial
• Report Date: 12/08/2015

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: No Information
• Device Model Number: FL 19H
• Device Lot Number: FL19-0809
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2015
• Type of Device Usage: N
• Patient Sequence Number: 1