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

Model Number 4AM663

Device Problems Misassembled (1398); Unstable (1667)

Patient Problem Fall (1848)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

Unique complaint id# (b)(4), bed straps were attached to the bed by technician (b)(4) on 7/19/17.Customer does not require additional assistance.Based on the adverse event stated by the customer the complaint is reportable per cfr 21 803.3.

Event Description

Customer purchased the bed (b)(6) 2013, the bed was delivered (b)(4) 2013.Spoke to (b)(6), mrs.(b)(6) states the bases have separated a couple of times.She states one incident caused her husband to fall off the side of the bed causing him to hit his head and shoulder on the nightstand.Mrs.(b)(6) states they did not receive bed straps when bed was delivered.Customer cannot confirm the dates of the incident, mrs.(b)(6) confirms that her husband did not need medical attention at any time.

• 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: 6750302
• MDR Text Key: 81401132
• Report Number: 3008872045-2017-00020
• 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 Family Member or Friend
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: 4AM663
• 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: 06/16/2017
• Initial Date FDA 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): Other