MAUDE Adverse Event Report: CRAFTMATIC INDUSTRIES, INC. CRAFTMATIC MODEL1 BASE; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number 4AT058

Device Problem Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Three attempts have been made to reach customer to request pictures of the mattress but the customer has not responded.Due to no response or further action required by the customer, the complaint will be closed.If the customer calls for additional assistance with original complaint this complaint ticket will be reopened at that time.We requested pictures of mattress and the customer agreed, but never did.We requested the picture to better assist the customer with her complaint of the mattress being flat.

Event Description

Spoke to daughter, she says she found out her mother fell out of the bed on (b)(6) 2017, she states her mother was laying flat and slid off.Customer's daughter states her mother did not go to the hospital, nor did she call 911.Customer's daughter says the mattress is flat on one side.Her mother is (b)(6).She says the mattress also slides, she has not rotated the mattress and she has no mobility issues.

• Brand Name: CRAFTMATIC MODEL1 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: 7011624
• MDR Text Key: 91411262
• Report Number: 3008872045-2017-00037
• 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: Other
• Type of Report: Initial
• Report Date: 10/06/2017

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: 4AT058
• 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: 10/06/2017
• Initial Date FDA Received: 11/08/2017
• 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: 61