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

Model Number 4AT059

Device Problem Device Slipped (1584)

Patient Problems Bruise/Contusion (1754); Injury (2348)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(4).Spoke to (b)(6), confirmed that the non slip pads were installed on the bed sticky side up.Advised customer that the mattress should not be moving then.(b)(6) states the customer now requires the assistance of 2 physical therapists to get her in and out bed.Customer was advised by her physical therapist that the bed is not recommended for mrs (b)(6).A bed cane was recommended for the customer.

Event Description

Customer purchased bed on (b)(6) 2018 and bed was delivered on (b)(6) 2018 , spoke to (b)(6), she stated the mattress is sliding off the base.(b)(6) states the customer was trying to get out of the bed and the mattress slid.Customer weighs (b)(6) pounds.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC; 3580 gateway drive; pompano beach FL 33069
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 8202454
• MDR Text Key: 131595725
• Report Number: 3008872045-2018-00016
• 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: Repair
• Type of Report: Initial
• Report Date: 10/29/2018

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: 4AT059
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2018
• 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; Disability
• Patient Weight: 91