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

Model Number M1242-07

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

Patient Problems Fall (1848); Concussion (2192)

Event Date 08/06/2017

Event Type  Injury  

Manufacturer Narrative

Unique complaint id (b)(4).-sent non slip pads for customer on (b)(6) 2017 and were delivered on (b)(6) 2017.Customer confirms receipt of non slip pads.Customer will have her son in law install non slip pads on the base.No further assistance is needed.The customer has not indicated a malfunction, a defect of the device or an adverse event.Customer confirmed part receipt.

Event Description

Spoke to (b)(6) and she states she sat on the corner of the bed and remembers waking up at 4am on the floor.She states she could not recall how she got there or what may have happened.She states the mattress was behind her and the dresser was in front of her.The customer states 911 was activated and she was taken to the hospital.The customer states she suffered a concussion.Customer states she is unable to provide the date of the event; but that states it happened after (b)(6) 2017.Customer states she has mobility issues and requires a bed rail that she will obtain locally.Customer height: 5 10 and weight: (b)(6) pounds.

• 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: 6977184
• MDR Text Key: 90239151
• Report Number: 3008872045-2017-00029
• 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: 08/30/2017

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: M1242-07
• Device Catalogue Number: CMMOD1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 10/25/2017
• 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): Hospitalization
• Patient Weight: 61