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

Model Number 4AR384

Device Problems Misassembled (1398); Unstable (1667)

Patient Problem Fall (1848)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Ordered a set of bed straps.Customer states he requires installation of bed straps, a new ticket will be opened for installation.The installation is currently pending.

Event Description

Mr.(b)(6) states his wife got stuck between and twisted her shoulder.He states he had to pull the beds apart to get her out.Mr.(b)(6) states his wife weighs between (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: 7011626
• MDR Text Key: 91411864
• Report Number: 3008872045-2017-00038
• 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: Modification/Adjustment
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4AR384
• 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: 10/11/2017
• 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): Other
• Patient Weight: 45