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

Catalog Number FL14E1

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

Patient Problems Bruise/Contusion (1754); Laceration(s) (1946)

Event Date 10/09/2017

Event Type  Injury  

Event Description

It was reported that a patient was found with their foot entrapped in the siderail (zone 2).The patient alleged sustained a small laceration and bruising to the right foot, and was treated with tylenol.The unit was being used with a non-stryker foam mattress.

Manufacturer Narrative

The customer declined to have stryker evaluate the unit, as they had performed their own evaluation of the product and found no malfunction or defect.It was confirmed that no further action was required.

Event Description

It was reported that a patient was found with their foot entrapped in the siderail (zone 2).The patient alleged sustained a small laceration and bruising to the right foot, and was treated with tylenol.The unit was being used with a non-stryker foam mattress.

• Brand Name: LTC 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: 7139117
• MDR Text Key: 95524867
• Report Number: 0001831750-2017-00596
• 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: 08/03/2018

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: No Information
• Device Catalogue Number: FL14E1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 11/29/2017
• Supplement Dates FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other