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

Model Number 4AT057

Device Problem Missing Value Reason (3192)

Patient Problem Fall (1848)

Event Date 06/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Sent customer a set of 2 inch legs as a courtesy.Customer received the legs and a woman she knows installed them for her.Legs arrived on (b)(6) 2017.Confirmed with customer that the height is much better for her now and customer can get in and out the bed much easier.

Event Description

Customer purchased the bed (b)(6) 2017 and the bed was delivered (b)(6) 2017.Customer states she is in a wheelchair and had trouble getting into bed on (b)(6) 2017 due to the height of the bed.She states she lost her balance and slid off the mattress onto the floor.Customer states that she was unable to get up from the floor and called 911, customer states firemen helped her off the floor.Customer confirms she is not hurt and did not need any medical treatment.

• 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: 6750789
• MDR Text Key: 81298949
• Report Number: 3008872045-2017-00017
• 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: 06/08/2017

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: 4AT057
• 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: 06/08/2017
• Initial Date FDA Received: 07/28/2017
• 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: 109