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

Model Number 4AW099

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

Patient Problems Fall (1848); Hematoma (1884); Laceration(s) (1946); Swelling (2091)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(4).Spoke to (b)(6) on (b)(6) 2019, he would still like his bed lowered 2 inches but declined any further assistance at this time, customer will consult with his lawyer before moving forward.

Event Description

On (b)(6) 2019 mr (b)(6) claims that he was trying to get into bed, he shifted around and fell.He hit the nightstand and got blood on his mattress.Claims he hit his elbow, shoulder, arm and knee, leg and ankle are swollen.Son could not get him up so they called 911 and he was transported to a hospital where he stayed about 3 days and paid about (b)(6) per day/copay.Customer claims they just put band-aids on him since he takes blood thinners.Customer is 6 foot tall and weighs (b)(6).Customer claims had fallen a couple of years ago, he uses a walker and does not trust himself walking.Customer also has copd.Customer kept talking about being compensated (b)(6) for staying in the hospital and said that compensation of the (b)(6) will probably make him go away.Customer wanted the bed 2 inches lower.In the end he mentioned that he may go away if we credit the money he paid for hospital stay.Customer also mentioned something about (b)(6) for a mattress and the blood on it is not his fault although i cannot find any information that a mattress replacement was discussed with him.

• 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 (Section G): CRAFTMATIC INDUSTRIES, INC; 3580 gateway dr; pompano beach FL 33069
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; ft. lauderdale, FL 33312
• MDR Report Key: 8780757
• MDR Text Key: 150732998
• Report Number: 3008872045-2019-00006
• 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: 04/30/2019

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: 4AW099
• Device Catalogue Number: CMMOD1
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 07/11/2019
• 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 Weight: 113