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

Catalog Number CMMOD1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

Unique compliant id # (b)(4).Customer was sent a set of non slip pads.On (b)(6) 2017 technician installed non slip pads on customer's bed under the mattresses.Customer confirmed that service has been completed and is happy.No further assistance is required by the customer.

Event Description

Bed was purchased (b)(6) 2011 and base was delivered (b)(6) 2011.Mattresses were ordered (b)(6) 2011, delivered in (b)(6) 2011.Spoke to (b)(6).Mattresses separated while she slept.She states she tried to reach the top of the mattress to pull herself up and cut her pinky finger (right hand) on the "wood on the bed".Customer understands that there is no material in the mattress that would cut her.Customer is unsure of when incident occurred.Customer was taken by caregiver to her primary doctor for her injury, she states x-rays were performed and confirmed that the doctor found no fractures or breaks on the x-rays.

• 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: 6746534
• MDR Text Key: 81150571
• Report Number: 3008872045-2017-00018
• 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: Modification/Adjustment
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• 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: 06/09/2017
• Initial Date FDA Received: 07/27/2017
• 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): Other
• Patient Weight: 75