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

Model Number 4AM668

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

Patient Problems Fall (1848); Fracture, Arm (2351)

Event Date 06/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4), sent ms.(b)(6) non-slip pads to place under her mattresses to prevent from sliding.Technician has a service visit pending to install non-slip pads to the base on (b)(6) 2017.Based on the adverse event stated by the customer the complaint is reportable per cfr 21 803.3.(b)(4) filed.A follow up shall be submitted to the fda upon completion if service visit.

Event Description

Customer purchased the bed (b)(6) 2013, the bed was delivered (b)(6) 2013.Spoke with (b)(6), she states that she has fallen out of bed on multiple occasions.She states the issue is that the mattresses are too narrow and at times slide on the base.The customer states the first time, she fell by rolling off the right side of the bed.She said that she fell to the floor, and broke her arm.She did seek medical attention.Customer is unable to provide the dates of the fall.The other incidents involved falls that caused her to hit her head and her shoulder, for these incidents the customer denies seeking medical attention.

• 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: 6750240
• MDR Text Key: 81270102
• Report Number: 3008872045-2017-00014
• 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: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4AM668
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2017
• 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: 82