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

Model Number 4AT058

Device Problems Component Falling (1105); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer was shipped headboard brackets (b)(6) 2017, expected delivery date per delivery site is (b)(6) 2017.A technician will be scheduled to install headboard brackets, upon customer confirmation of headboard bracket receipt.A follow up submission confirming installation will be submitted when available.

Event Description

Spoke to (b)(6).Customer states her original bed and replacement bed did not include the headboard brackets.Customer states that because the headboard is not attached; when she raises the head of the bed, the headboard raises as well causing the headboard to hit smack her on the head.Customer confirms that she has not sought medial attention and has not been injured.Customer was unable to disclose the exact dates of incident.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC; 5192 sw 27th ave; fort lauderdale FL 33312
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 7117973
• MDR Text Key: 94863678
• Report Number: 3008872045-2017-00046
• 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: Repair
• Type of Report: Initial
• Report Date: 11/16/2017

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: 11/16/2017
• Initial Date FDA Received: 12/14/2017
• 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