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

Model Number 4AR795

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

Patient Problems Fall (1848); Hematoma (1884); Laceration(s) (1946)

Event Date 06/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).On may 24 2017 12:42 pm, an attempt was made to schedule a service visit for he installation of the bed strap, customer declined service stating that bed straps have been installed on her bed by someone she hired.

Event Description

Customer purchased the bed base april 4, 2016.Product was delivered 4/15/2016.Customer states she did not receive bed straps at the time of delivery.Customer requires a service visit for the installation of the bed straps.Manna has contacted us by email and advised that they are not able to reach customer to schedule installation of the bed straps.When customer was contacted, mrs.(b)(6) explained she lost her balance and fell because the entire bed moved when she attempted to get out of bed at 6:30 am on (b)(6) 2016.She states she hit a sharp corner of her nightstand.Customer states she called 911 because she could not move and could not get up.Mrs.(b)(6) states she went to the emergency room at (b)(6) memorial hospital in (b)(6), where she was treated, she states received 3 stitches in her lip.Msr.(b)(6) states she had some bruising on her right leg.She has confirmed that her bed is on hardwood floors, but cannot tell me if she has caster cups.She stated that the bed is moving and she is in fear of falling again.Customer was to have the bed straps installed at no charge but the customer refused the service visit.Customer informed me that her handyman came and strapped her bed together.Mrs.(b)(6) confirms that the beds are stationary and do not move.Customer states that her husband attempted to send 2 emails regarding the incident but mrs.(b)(6) was unable to confirm who the emails were sent to.

• 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 (Section G): 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: 6635572
• MDR Text Key: 77405052
• Report Number: 3008872045-2017-00013
• 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: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/16/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4AR795
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: No
• 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