MAUDE Adverse Event Report: HARD MFG. CO., INC. HARD CRIB; BED, PEDIATRIC OPEN HOSPITAL

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Stryker medical was notified of a potentially reportable complaint involving a product for which stryker is not the original equipment manufacturer of the reported device.The customer alleged a hard crib, serial number (b)(6), had malfunctioning latch assembly.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

Event Description

Additional information received on 3/1/2024 for report mw5135934 to update procode.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: HARD CRIB
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): HARD MFG. CO., INC.
• MDR Report Key: 17529005
• MDR Text Key: 321455443
• Report Number: MW5135934
• Device Sequence Number: 1
• Product Code: FMS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2024
• Patient Sequence Number: 1