MAUDE Adverse Event Report: JOERNS HEALTHCARE CARE WIDE EXTENSION KIT; BED WIDTH EXTENSION

Model Number COMFEXT_KIT

Device Problem Misassembly by Users (3133)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 06/15/2014

Event Type  Injury  

Event Description

It was reported to the mfr by the facility (b)(4), per the facility, the resident was assisting the staff in rolling herself over so the sheets could be changed.The resident was pulling on the rail and the comfext came off the bed.The resident rolled off the bed and landed on the floor.The resident was transported to the hospital for x-rays and she sustained a broken cheek bone.Complaint # (b)(4) and ra# (b)(4) were entered into our system to return the comfext to joerns for investigation.As of this writing, the comfext has not been received at joerns.

• Brand Name: CARE WIDE EXTENSION KIT
• Type of Device: BED WIDTH EXTENSION
• Manufacturer (Section D): JOERNS HEALTHCARE; matamoros, tamaulipas ; MX
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014-0000 ; 8008260270
• MDR Report Key: 3955166
• MDR Text Key: 4559123
• Report Number: 3009402404-2014-00017
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: COMFEXT_KIT
• Device Catalogue Number: COMFEXT_KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2014
• Distributor Facility Aware Date: 06/15/2014
• Device Age: 7 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/15/2014
• Date Manufacturer Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 150