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

Model Number M9061-07

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

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Unique complaint id (b)(4).The customer was advised that sue to the soiled mattress a replacement will not be provided.The customer was advised on how to safely enter and exit the base.No further assistance was required.Craftmatic is presently in the process of obtaining a udi.

Event Description

Spoke to mr.(b)(6), he claims the mattress sags.He states that on 2-3 occasions he has rolled out of bed and has fallen on the floor.He states he was unable to get up and has had to call the fire department for assistance several times.The customer confirmed that he has never been injured.Customer states he purchased a rail (a metal bed cane) from (b)(6) and confirms he has not rolled onto the floor since he installed the metal bed rail (bed cane).The customer states that the issue with the mattress began after he started urinating on the mattress.The customer has also put a topper on the mattress.That made the slope easier to deal with.Customer is 6 foot 2 and weighs (b)(6) pounds.Customer confirms he is handicapped.Due to health and age, he does not feel comfortable getting in and out of bed by himself.He normally has another person present for assistance.The customer states he has mobility issue and uses a walker and scooter.Gets in and out of bed when it is elevated.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES; 3580 gateway drive; pompano beach, fl
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES; 3580 gateway drive; pompano beach, fl
• Manufacturer Contact: jessica vivar ; 3580 gateway drive; pompano beach, fl ; 82808933
• MDR Report Key: 10220363
• MDR Text Key: 197947604
• Report Number: 3008872045-2020-00008
• 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: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M9061-07
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2020
• 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: 110