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

Model Number 4AR795

Device Problem No Apparent Adverse Event (3189)

Patient Problems Fall (1848); Hematoma (1884)

Event Date 07/20/2019

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(6).On (b)(4) 2019, service manager spoke with the customer's daughter and advised her to obtain a bed rail for containment due to her fathers needs, (b)(6) was also advised that the bed rail is only for containment not for leverage.(b)(6) was provided the phone number of seg sales for assistance with purchasing the rail.

Event Description

(b)(6) called in and advised that on (b)(6) 2019 her father, (b)(6) fell out of the bed.She states her father was sleeping in an elevated position and rolled over causing him to fall from the bed and causing the mattress to move as well.She states her father suffered a black eye, bruised nose, bruised right elbow and knee.She advised that her father weighs (b)(6) and confirms that her father did not seek medical attention.Mr.(b)(6) confirms that the base has bed straps connecting the bases together and that the base is on carpeted flooring.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC.; 5192 sw 27th ave; ft. lauderdale FL 33312
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC.; 3580 gateway dr; pompano beach FL 33069
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; ft. lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 8905585
• MDR Text Key: 155031340
• Report Number: 3008872045-2019-00011
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4AR795
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• 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
• Patient Weight: 77