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

Model Number 4AM663

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Hematoma (1884)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

Sent customer 2 sets of caster cups.Caster cups were delivered on (b)(6) 2017.Customer confirmed part receipt, her son will install them under the bed.No further assistance is needed.

Event Description

Mr.(b)(6) fell off of the bed at night while getting up to use the restroom.The bed slid out from underneath him, and he fell on the floor.This happened about 2 months after his bed was delivered, but she does not remember the exact date that he fell.He has not used his bed since, for fear that he might fall again.He was not injured severely, just some bruising on his elbow, and knee.He did not seek any medical attention.Mr.(b)(6) does not have any mobility issues that prevent him from needing assistance getting in and out of bed.

• 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: 6977088
• MDR Text Key: 90250447
• Report Number: 3008872045-2017-00024
• 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 Family Member or Friend
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/07/2017

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: 4AM663
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 10/25/2017
• 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: 82