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

Model Number 4AR790

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

Unique id# (b)(4).Customer was shipped a set of 4 inch legs which were delivered on (b)(6) 2019.On (b)(6) 2019 the customer, (b)(6) confirmed that the legs arrived and her son will install them on the bed at his leisure.The customer is satisfied and requires no further assistance.

Event Description

Mrs.(b)(6) called in to advise she took a bad fall off of her bed and needs the height lowered.Mrs sword states the incident occurred (b)(6) 2019, she did not call 911 but did see her primary doctor to rule out that nothing was broken.Customer has 9 inch legs and wishes to get 4 inch legs.

• 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; ft. lauderdale FL 33312
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC.; 5192 sw 27th ave; ft. lauderdale FL 33312
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; ft. lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 8817394
• MDR Text Key: 151918695
• Report Number: 3008872045-2019-00009
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4AR790
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• 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