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

Model Number M9511-07

Device Problem Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer was sent 2 sets of non slip pads and they were delivered on 5/20/2015.Customer stated that the issue was not resolved, so another 2 sets of non slip pads were sent to customer and delivered on 7/18/2015.Customer stated today that this has not resolved the issue.Customer prefers that she no longer be contacted in regards to this issue.The customer requires no further assistance.

Event Description

Customer states the mattresses are separating.On (b)(6) 2017, per mr.(b)(6), he confirms the bases are not separating, the mattresses are.Customer was sent 2 sets of non slip pads to prevent movement of mattress and the no slip pads have not resolved the issue.The mattresses separated and the customer has fallen to the floor more than once, last time was about a month ago.Customer confirms she suffered back pain from the fall.Customer did not call 911, but did see her doctor and had mri's and a full body scan done to her.Mr.Said that non slip pads were sent and they were installed on the bed.Customer could not confirm the date of incident.

• 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: 6983124
• MDR Text Key: 90409853
• Report Number: 3008872045-2017-00033
• 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: Modification/Adjustment
• Type of Report: Initial
• Report Date: 09/05/2017

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: M9511-07
• 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: 09/05/2017
• Initial Date FDA Received: 10/27/2017
• 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): Required Intervention