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

Model Number 4AR790

Device Problems Misassembled (1398); Unstable (1667)

Patient Problem Fall (1848)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Bed straps were on back order and were sent 7/26/2017.Technician has a service visit pending to install bed straps.On 8/15/2017 technician serviced the bed, installed bed straps.Confirmed with customer that service ha been completed, bases are no longer separating.

Event Description

On (b)(6) 2017, mrs.(b)(6) states she fell in between both bed bases and mattresses.She states she had previously broke her arm and when she fell between the beds, she twisted her arm again.She went to the doctor and got x-rays.Customer does not have medical records in home.The customer states this incident happened 3 months ago but cannot recall the exact date.Customer's height is (b)(6).

• 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 ; 7411 fisher island drive; miami beach, FL 33019-0700 ; 9548280893
• MDR Report Key: 6981780
• MDR Text Key: 90386471
• Report Number: 3008872045-2017-00022
• 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: Repair
• Type of Report: Initial
• Report Date: 07/03/2017

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: 4AR790
• Device Catalogue Number: CMMOD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 10/26/2017
• 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: 87