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

Model Number 4AW099

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problem Fall (1848)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(6) on (b)(6) 2019 the customer, mary greener has stated that her son or son in law installed the retainer bar into bed and the bed functions as it should.Representative from pilot confirms that the technician did not fulfill the service visit.No further assistance is required.

Event Description

Spoke with mary greener, she claims she sat on the left corner of the bed to put on her pants, the foot went down and she fell onto the floor.Customer got back up and states she did not get hurt and did not seek medical treatment.Mrs.Greener claims the foot of the bed was flat when she sat on the left corner of the bed.This happened about 2 days ago.Mrs.Greener states she tried to put the piece (retainer bar) into the holes but was unable to.She states she mostly has the bed in the flat position and does not elevate the bed much.Mrs.Greener states she removed the retainer bar to see if it would solve her issue, but it did not.Mrs.Greener states she weighs 170 pounds.Customer confirms that she does not have mobility issues and gets in and out of bed on her own.Customer cannot confirm if the retainer bar bushings are in the base but was able to re-install the retainer bar.Mrs.Greener states she continues to have the same problem when she sits in the corner of the foot of the bed.

• 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: 9179323
• MDR Text Key: 168652967
• Report Number: 3008872045-2019-00013
• 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: Notification
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4AW099
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2019
• 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: 77