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

Model Number 4MA663

Device Problem Material Torqued (2980)

Patient Problems Fall (1848); Hematoma (1884)

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sent customer 2 sets of non slip pads as a courtesy.Non slip pads were delivered on 8/2/2017.Customer confirmed receipt of non slip pads, mattresses are not moving and no further assistance is needed.Based on the information provided by the customer; the complaint is reportable per cfr 21 803.3.(b)(4).

Event Description

Customer states she was asleep and rolled into an iron nightstand and onto the floor due to mattresses moving.Customer states she hurt her face around her eye , cheek, jaw and shoulder area and has sustained bruising from the fall.Customer alleges she has fallen from the bed 3 times in the last month ((b)(6) 2017).And that she recently had a shoulder replacement.Customer did not seek medical attention due to fall.Customer is (b)(6).

• 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: 6977080
• MDR Text Key: 90958987
• Report Number: 3008872045-2017-00023
• 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: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4MA663
• 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: 07/28/2017
• 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; Other
• Patient Weight: 77