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

Model Number M9511-07

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

Patient Problem Fall (1848)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

Unique id 2020-001013.Spoke to (b)(6).Customer emailed pictures.I inspected the pictures and an issue was not visible.The customer's complaint is that the memory foam bends under customer's weight.She feels that the mattress is too soft for her husband.I explained that this is a memory foam mattress, it will compress under his weight.Also, it is an adjustable mattress and it will bend on the side when being sat on.Does not seem to be the issue when he is laying in the bed.Advised customer that we can offer pro rata warranty, but it will be a memory foam mattress, if customer wishes to acquire a different mattress we can sell a new mattress at full price.The customer stated that she did not know mr.Was going to get this disease when they bought the bed.A bed rail was recommended, but the customer said her husband will climb over the railing.The customer has not indicated a malfunction, a defect of the device or an adverse event.The customer has not indicated a malfunction, a defect of the device or an adverse event.Craftmatic is presently in the process of obtaining a udi.

Event Description

Customer purchased bed on (b)(6) 2015, bed was delivered on (b)(6) 2015.Spoke to (b)(6).Customer claims that her husband's mattress sags.Mrs.(b)(6) states that her husband has fallen out of the bed 4 times.Mr.(b)(6) has dementia and parkinson's states her husband rolls over and rolls out of the bed.She confirms that her husband was not hurt but she did take him to the hospital just to be sure.Mr.(b)(6) is (b)(6) years old and weighs (b)(6) pounds.Mrs.(b)(6) states that she has placed a firm non adjustable mattress on the base and confirms that he has not fallen out of the bed since, she also confirms that they no longer use the adjustable base features.

• 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 33069
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES; 3580 gateway drive; pompano beach FL 33069
• Manufacturer Contact: jessica vivar ; 3580 gateway drive; pompano beach, FL 33069 ; 9548280893
• MDR Report Key: 11092370
• MDR Text Key: 224250425
• Report Number: 3008872045-2020-00011
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220387
• 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: 12/29/2020

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: M9511-07
• Device Catalogue Number: CMMOD1
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 12/29/2020
• 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): Hospitalization
• Patient Age: 78 YR
• Patient Weight: 91