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

Model Number M1242-05

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(4).Reached out to (b)(6) on (b)(6) 2019 at 11:37 am pacific time, the customer has not taken the pictures of the mattress yet stated that the mrs.Fell out of bed last night.Asked customer if she can sleep somewhere else in the mean time if this is an issue.Asked if they could swap beds for now, the customer has not considered that, but may now.Also discussed a bed cane, a device to assist customer staying in bed, it seems that this may be needed.The customer is busy with an appointment this week, he will take a picture next week.When additional information is available a follow up submission form will be submitted to the fda.

Event Description

On (b)(6) 2019 at 1:22 pm pct, i spoke to mr.(b)(6).The customer has a queen sized bed that he and his wife both use.Claims that they raise the bed in the evening to watch tv, then they flatten the bed and there is a crease or a depression remaining from the elevation.Claims the mrs.Slid out of bed three to four times in the last couple of weeks.She was not injured and no medical assistance was sought.They have rotated the mattress, but have not flipped it.The bend is in the middle.The customer believes that the reason the mrs.Has slid out of bed is because she sleeps on her side and the dip lets her slide out, he sleeps on his back and does not slide out of bed.The mrs.Is not bed ridden and does not require assistance in getting in and out of bed, she is mobile, in her 60s and weighs about 150-160 pounds, but he is not sure.The mrs.Sleeps on her side facing the middle with her legs bent (fetal position) and her back side slides out.The mattress has become softer in the middle.I have requested pictures from customer.He is in his 80s and is on dialysis, unable to take the information down.Asked customer to have his wife call us when shew is available so i provide a delivery method for the pictures.The customer stated that he will follow up on that as soon as he can and mentioned casually that he used to work for a personal injury law firm for a few years.

• Brand Name: CRAFTMATIC MODEL 1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC.; 3580 gateway dr; pompano beach FL 33069
• 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: 9602518
• MDR Text Key: 176611830
• Report Number: 3008872045-2020-00001
• 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: Notification
• Type of Report: Initial
• Report Date: 12/17/2019

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: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/17/2020
• 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 Age: 60 YR
• Patient Weight: 73