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

Model Number M1242-05

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 11/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Sent customer a set of non slip pads.Customer was educated and informed that the bag is designed to be thrown away at the time of the delivery and is not meant to be use for preserving the mattress.It was suggested that the customer should use a mattress pad/protector to protect the mattress, the customer hung up the phone and refuses to answer any of our calls.

Event Description

On (b)(4) 2018, customer was contacted to confirm the receipt of the non slip pads, the consumer alleges she was in the hospital for back surgery due to a fall she sustained because the mattress moved.Customer stated that she kept the plastic bag from the manufacturer on the bed to preserve the mattress.Customer confirms the mattress movement is due to the bag on the mattress.

• 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: 8202457
• MDR Text Key: 131595669
• Report Number: 3008872045-2018-00017
• 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: Other
• Type of Report: Initial
• Report Date: 12/19/2018

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: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/28/2018
• 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): Hospitalization; Other