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

Catalog Number FL23SE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Physical Entrapment (2327)

Event Date 03/21/2014

Event Type  malfunction  

Event Description

It was reported that allegedly a patient got his foot stuck between the 2 siderails and allegedly sustained bruising.

Event Description

It was reported that allegedly a patient got his foot stuck between the 2 siderails and allegedly sustained bruising.

Manufacturer Narrative

It was initially reported that allegedly a patient got their foot stuck between the 2 siderails and allegedly sustained bruising.It was further reported that an x-ray showed the patient had a tibial-peroneal fracture.The patient has since recovered.No malfunction was found with the bed.

• Brand Name: ELECTRIC 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: 3748970
• MDR Text Key: 4421233
• Report Number: 0001831750-2014-02894
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2014

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?: No
• Device Operator: Other
• Device Catalogue Number: FL23SE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2014
• Initial Date FDA Received: 04/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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