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

Model Number 4AM668

Device Problem Unintended Movement (3026)

Patient Problems Eye Injury (1845); Fall (1848)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

Unique complaint id (b)(4).-customer's daughter and husband use the bed and will be purchasing non slip pads locally to prevent any mattress movement.The customer requires no further assistance.

Event Description

Customer purchased bed (b)(6) /2014 and bed was delivered (b)(6) 2014.Customer's daughter states her father was getting out of the bed and the mattress moved to the side as her father was rolling over; causing him to fall out of bed, hit his eye on the corner of the nightstand and fall to the floor.The customer's daughter states her father did seek medical attention from a "eye specialist" due to the black eye he sustained.The customer's daughter is unable to provide the time and date of the fall.The customer's daughter states that a bed rail was placed on the bed to prevent her father from falling after the incident.The customer's daughter is presently using the bed.

• 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 Contact: jessica vivar ; 7411 fisher island drive; miami beach, FL 33019-0700 ; 9548280893
• MDR Report Key: 6977180
• MDR Text Key: 90238589
• Report Number: 3008872045-2017-00028
• 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 Family Member or Friend
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 08/28/2017

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: 4AM668
• Device Catalogue Number: CMMOD1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 10/25/2017
• 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): Other