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

Model Number 4AR793

Device Problem Insufficient Information (3190)

Patient Problems Eye Injury (1845); Fall (1848)

Event Date 11/23/2018

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(4).Spoke to (b)(6) on (b)(6) 2018, she told me she was sitting up in bed reading when all of a sudden the head of her bed sprung upwards and sprung her out of bed where she hit her head on the nightstand.I proceeded to ask the customer questions but she seemed incoherent.When i explained it is impossible for the head of the base to move that way, she disagreed with me.I asked if it was at all possible that she was sitting on the remote and she confirmed that she was not.She confirmed that no medical attention was needed.She stated that she injured her eye.I told her someone will call her on monday and the customer proceeded to provide the last 4 digits of her social.She also mentioned that her husband recently died and she cannot afford a tomb stone.(b)(6) 2018, refund was provided via (b)(6).

Event Description

Spoke to (b)(6) on (b)(6) 2018, she told me she was sitting up in bed reading when all of a sudden the head of her bed sprung upwards and sprung her out of bed where she hit her head on the nightstand.I proceeded to ask the customer questions but she seemed incoherent.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC; 5192 sw 27th ave; fort lauderdale FL 33312
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC; 5192 sw 27th ave; fort lauderdale FL 33312
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 8334904
• MDR Text Key: 136003223
• Report Number: 3008872045-2019-00002
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K0022387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 02/12/2019

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: 4AR793
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2019
• Initial Date FDA Received: 02/13/2019
• 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