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

Model Number M9515-07

Device Problem Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Ordered customer a set of non slip pads on 10/4/2017 for customer to install.Spoke with mr and mrs (b)(6) who confirmed the receipt of the non slip pads.Mrs (b)(6) will install them.Mr (b)(6) has doctors appointment on (b)(6) 2017, to get hip checked.On 10/17/2017, spoke to mr.(b)(6), he received the non slip pads and does not like them.Says they do not hold the mattresses on the bed well.Advised customer that as of right now the non slip pads that we provided is all that we have for this issue.Customer is not happy and does not like the bed, says if he falls out of the bed again, we will have problems.

Event Description

Spoke to (b)(6), customer states, he was getting into bed this morning, the mattress slid and he fell onto the floor causing him to hit his leg and bottom on the wheels of the power chair.Customer disclosed that he has some mobility issues due to his knee and ankle.Customer is (b)(6) pounds.Customer states he has pain to his left hip and is self medicating with hydrocodone.Customer confirms that he has always suffered from hip pain but adds that the fall made the pain worse.Customer states the hydrocodone was prescribed for his knee and ankle.

• 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 ; 2411 fisher island drive; miami beach, FL 33019 ; 9548280893
• MDR Report Key: 7004472
• MDR Text Key: 92114461
• Report Number: 3008872045-2017-00034
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 10/04/2017

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: M9515-07
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 11/06/2017
• 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
• Patient Weight: 131