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

Model Number 4AR790

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Hematoma (1884); Laceration(s) (1946); Injury (2348)

Event Date 12/27/2018

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(4).Customer would like a firmer mattress for her father; a firm mattress will be ordered and shipped to the customer.The delivery date is pending.

Event Description

Spoke with (b)(6); she stated there is some issues with the bed she purchased for her father.She states that the mattress moved off the bed base when her father was attempting to get out of bed, causing him to fall.Her father suffered bruising and a laceration to his right eye.911 was contacted and her father was taken to the emergency room.She confirms that her father has mobility issues and requires the assistance of a walker.She states her father lives in an adult living facility, (b)(6) retirement community in (b)(6).The customer's daughter confirms that her father is entering and exiting the bed in the elevated position; customer was advised that the it is not suggested to enter or exit the bed in the elevated position because of the stability of mattress.

• 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; fort lauderdale FL 33312
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC; 5192 sw 27th ave; fort lauderdale FL 33312
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 8267469
• MDR Text Key: 133743890
• Report Number: 3008872045-2019-00001
• 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: Replace
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• 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
• Date Manufacturer Received: 12/27/2018
• 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