MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO FLORENCE DC W/REGULAR SIDERAIL; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number FL23SE-STD

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

Patient Problem Laceration(s) (1946)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted by stryker medical as the importer.(b)(4).Evaluation was performed by stryker.

Event Description

It was reported that the patient was found by the nurse with their legs stuck in the foot left siderail.It was further reported that the patient's right leg was lacerated about 30 cm (on the tibia) and required approximately 20 stitches.The unit was evaluated by stryker and no malfunction or defect was found.

• Brand Name: FLORENCE DC W/REGULAR SIDERAIL
• 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: 7371124
• MDR Text Key: 103479769
• Report Number: 0001831750-2018-00171
• 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: Distributor
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2018

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: FL23SE-STD
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2018
• Distributor Facility Aware Date: 03/05/2018
• Device Age: 62 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2013
• 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