MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SECURE II MED/SURG BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 3002 EX

Device Problem Component Missing (2306)

Patient Problem Injury (2348)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

Several attempts have been made to reach the customer for additional information regarding the alleged injury, but to date, the attempts have not been successful.

Event Description

It was reported that the footboard lid was missing and the patient allegedly cut their foot on the metal footboard hinge.The severity of the alleged cut and whether or not any medical intervention was required is not known.

• Brand Name: SECURE II MED/SURG BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6413820
• MDR Text Key: 70243318
• Report Number: 0001831750-2017-00075
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3002 EX
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1