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

Model Number 4AV740

Device Problem Missing Value Reason (3192)

Patient Problem Fall (1848)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).On 11/13/2017, ordered customer a set of 2 inch legs.On 11/15/2017, spoke to (b)(6),he received the legs for his bed and called back to have the legs installed for him.Ordering a technician to install his 2 inch legs.On 12/12/2017 spoke with mr.(b)(6), he confirmed the technician had installed the legs on 11/16/2017.

Event Description

Spoke to (b)(6), customer states the bed is too high.He customer states he was trying to get into the bed from the wheelchair, the wheelchair moved causing customer to fall.Customer states he fell on (b)(6) 2017.Customer states he had to call 911 because he could not get off of the floor, customer disclosed he does not have legs.Customer did not sustain any injuries or go to the hospital.Customer weighs (b)(6) pounds.

• 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 Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 7112274
• MDR Text Key: 94652006
• Report Number: 3008872045-2017-00045
• 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: Replace
• Type of Report: Initial
• Report Date: 11/13/2017

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: Lay User/Patient
• Device Model Number: 4AV740
• 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: 11/13/2017
• Initial Date FDA Received: 12/13/2017
• 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
• Patient Weight: 76