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

Model Number 4AW097

Device Problem Installation-Related Problem (2965)

Patient Problem Fall (1848)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Spoke to (b)(6).The customer paid her friend to complete the installation of the bed straps for her.He attached the headboard, lowered the bed by 3 and a half inches, installed bed straps and flipped her mattress.The customer wants a rail, recommended a bed cane and advised not to install it where the bed bends, the customer is familiar with that piece.Her technician also tacked up the wires.The customer is very happy with the bed and will not trade it for the world.

Event Description

Spoke to (b)(6).Customer claims the bases were not strapped together, the headboard was not attached and the bed is not comfortable.The customer was getting into bed when the bases separated and she fell on the floor (recent back surgery).She called someone she knows who works at the fire department, who helped her get up off of the floor.Customer claims she is not hurt and did not seek medical attention.She fell last night at about 10 pm.The floor in bedroom is hardwood.The customer has a 4aw bed, this model does not come with casters, just the leg as it should.Customer had back surgery about 5 years ago.Uses a walker, can get in and out of bed by herself.Advised to get in and out of bed in the flat position, customer understands.She is 5 foot 9 and 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 dr; pompano beach FL 33069
• 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
• MDR Report Key: 9296668
• MDR Text Key: 185186520
• Report Number: 3008872045-2019-00018
• 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: 11/08/2019

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: 4AW097
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/08/2019
• 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: 141