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

Model Number 4AM663

Device Problem Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 12/24/2014

Event Type  Injury  

Manufacturer Narrative

The following information was received from the third party administrator for the liability insurance from the base component supplier (supplier names and complainant names redacted): our first notice of this claim was a letter from their attorney dated (b)(6) 2015.Since then we have attempted to reach out to their attorney but have been given limited information.We placed the caster supplier on notice as they possibly could be the caster cup manufacturer involved in the alleged complaint.They too have had limited discussions with the attorney.Neither caprin ( the caster cup manufacturer) or leggett and platt ( the bed base manufacturer) have been unable to inspect the alleged defective casters to determine: defectiveness and who is the manufacturer of the caster cups in question.Alleged injuries to complainant (b)(4) are to the back, neck and head, which allegedly required surgery and time off from work.The bed is still being used, the casters are in the possession of their attorney.The complainant ((b)(4)) was attempting to get into bed when the wheels malfunctioned by unlocking causing the bed to move out from under the complainant ((b)(4)).The wheels had been locked by the installers, come unlocked, and relocked just the day before by the son of the complainant ((b)(4)), so they are sure they were in the locked position.The incident happened on cement floor.The product was purchased on (b)(6) 2014 from craftmatic internet sales.Set up was facilitated by craftmatic internet sales.The device was delivered and assembled by (b)(4).At this present time we ar holding pattern until the attorney allows the parties to inspect and test the casters.

Event Description

Complaint (b)(4) allegedly sustained personal injuries when the wheels of the bed failed to lock causing complainant (b)(4) to fall.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE, PRODUCT CODE: LLI
• 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 33141 ; 9548280893
• MDR Report Key: 6147456
• MDR Text Key: 61532832
• Report Number: 3008872045-2016-00002
• 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: other
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4AM663
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2014
• 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