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

Model Number 4AT060

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Fall (1848)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(6).Customer was sent a set of 3 inch legs that were delivered to customer on (b)(6) 2019.Per (b)(4), a representative at pilot, service was completed by their technician on (b)(6) 2019.On (b)(6) 2019 customer, (b)(6) confirmed that the three inch legs have been installed on the bed and the customer has no trouble getting in and out of bed.Customer is happy with height of bed and service and requires no further assistance.

Event Description

Customer purchased bed on (b)(6) 2017, bed was delivered on (b)(6) 2018.Spoke with (b)(6) she stated her bed is to high.Customer states that she has fallen out of bed due to the height and confirms that she has not been injured due to fall.Mrs.(b)(6) states that she has not required medical attention.Mrs.(b)(6) states she lives in a assisted living facility.

• 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: 8390120
• MDR Text Key: 137821470
• Report Number: 3008872045-2019-00004
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4AT060
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• 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