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

Model Number M1242-05

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

Unique id: (b)(4).Customer would like to return the mattress and base, customer was advised that the a return is not possible.An inspection of the mattress and base was requested from pilot on 8/13/2019.The inspection was performed on 8/22/2019 - the results concluded that no defects were present, the mattress and base are stable and were installed properly.Three attempts have been made to reach customer to confirm service with no response from the customer.This complaint ticket will be closed.If the customer calls for assistance a new ticket will be opened at that time.Based on the information provided by the customer; the complaint is reportable per cfr 21 803.3.Mdr (b)(4).

Event Description

Spoke to (b)(6).Customer claims that the mattress is flimsy and sinks in.Customer is (b)(6), she is 5 foot 6.Customer states she slid onto the floor on two separate occasions while sitting on the edge of the mattress.On one occasion she required assistance from 911 to get off the floor due to a recent hip surgery on (b)(6) 2019.Customer stated the other time her brother helped her.Customer confirms that she was not hurt and did not fall onto the floor, she just slid down onto the floor, she states she was on medication and does not remember the exact date the incident occurred only that she is certain the incidents occurred after she came home from the hospital on (b)(6) 2019.Customer will start using a cane now.She confirms her mobility is okay but has trouble getting in and out of bed.Customer states she has a tendency of leaning forward.Customer confirms the back of her knees are against the mattress when she sits on the edge and confirms she has been getting in out and out of bed while it is in the flat position for the last couple of weeks.Customer claims the bed was flat when she slid off.

• Brand Name: CRAFTMATIC MODEL 1 BSSE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC.; 5192 sw 27th ave; ft. lauderdale FL 33312
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC.; 3580 gateway dr; pompano beach FL 33069
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; ft. lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 8982662
• MDR Text Key: 161608056
• Report Number: 3008872045-2019-00012
• 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: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/10/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: M1242-05
• Device Catalogue Number: CCMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 70 YR
• Patient Weight: 104