MAUDE Adverse Event Report: CRAFTMATIC INDUSTRIES, INC. CRAFTMATIC MODEL 1 BASE; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number 4AR790

Device Problem Component Missing (2306)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

A technician was scheduled for a service visit on 3/15/2017 for the installation of the bed strap kit to prevent sliding of the bed base.The service has been completed and the complainant requires no additional assistance.

Event Description

Complainant's wife contacted craftmatic industries on behalf of her husband, she states in (b)(6) 2017 at 3am, her husband attempted to get out of bed and the bed move away from him causing him to fall and break his right femur.The complainants wife is not sure of the actual date of the incident.The complainant is said to be (b)(6) years old.The complainants wife states he had to call 911 for assistance, she states her husband was admitted to (b)(6) hospital in (b)(6) for one week.The complainant is presently receiving rehabilitation services for his injury 3 times a week.The complainant's wife states they had issues with the bed sliding for some time prior to this incident.The complainants wife confirms the bed strap kit was not installed under the base at the time of the delivery on (b)(6) 2017.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC.; 7411 fisher island drive; miami beach FL 33019 0700
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC.; 7411 fisher island drive; miami beach FL 33019 0700
• Manufacturer Contact: jessica vivar ; 7411 fisher island drive; miami beach, FL 33019-0700 ; 9548280893
• MDR Report Key: 6432397
• MDR Text Key: 70812953
• Report Number: 3008872045-2017-00004
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/10/2017

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4AR790
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR