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

Model Number M1242-07

Device Problems Device Slipped (1584); Unintended Movement (3026)

Patient Problems Fall (1848); Hematoma (1884); Laceration(s) (1946); Swelling (2091); Injury (2348)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

Unique id (b)(6).Bases will picked up by pilot and will be returned for a full refund.The customer requires no additional assistance.

Event Description

On (b)(6) 2019 spoke to (b)(6) she states she has to get out of the bed a certain way, she states that when she went on the end of the mattress it flipped and flipped her onto the floor.She claims she hit her head, hip back and knee on the floor.She also states she cut her finger on the door.The customer states that she had a bruised hip and swollen cheek and eye as well as a knot on her heel as a result of the fall.The customer states she will be going to see her today ((b)(6) 2019).Customer states that she would like her husband to go back to the hospital bed he had before.Customer did not seek medical attention.She is (b)(6) 5 foot 2.No trouble getting in and out of bed normally.Uses a foot stool to get in and out of bed.

• 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
• MDR Report Key: 9335946
• MDR Text Key: 168678018
• Report Number: 3008872045-2019-00020
• 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: Replace
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M1242-07
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 71