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

Model Number 4AQ174

Device Problem No Apparent Adverse Event (3189)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

After further review, it was determined the logistics company that delivered the device (base and mattress) delivered a base that is not manufactured by craftmatic industries.This error was acknowledged and the logistic company has taken full responsibility for the error.The customer has decided to return the device (base and mattress) and a full refund will be issued.The complaint is reportable per cfr 21 803.3.

Event Description

Complainant purchased the base and mattress on (b)(6) 2017 and product was delivered (b)(6) 2017.Complainant states she was lying in bed and when she went to turn over, and the mattress flipped which caused the customer to fall on the floor.Complainant requested assistance and first aid from 911 police as well assistance to get up from the floor.Complainant states that she was not hurt.Complainant expressed that she was aware of the overlap of the mattress but assumed it was correct.

• 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 (Section G): 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: 6497314
• MDR Text Key: 72920006
• Report Number: 3008872045-2017-00005
• 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: Other
• Type of Report: Initial
• Report Date: 03/10/2017

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: 4AQ174
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: No
• 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