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

Model Number 4AT056

Device Problems Misassembled (1398); Unstable (1667)

Patient Problem Fall (1848)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

Unique complaint id (b)(6).Bed serial numbers that were attached (b)(4).On 12/15/2017 technician installed bed straps on customer's bed.Customer confirmed bed straps were installed successfully and is satisfied with service installation.Customer states everything is much better.Customer requires no further assistance.

Event Description

Customer purchased bed on (b)(6) 2017, bed was delivered on (b)(4) 2017.Spoke to (b)(4).Customer states on (b)(6) 2017, she was lying in bed, she tried to stretch on his side and hers, the beds separated and she fell onto the floor.Mrs.(b)(6) states that after an hour and a half of attempting to get up from the floor, she had to call 911 for assistance.Customer states she did not sustain any injuries she only disclosed that her hips and knees hurt and that the fall has affected her existing mobility issues.Customer states her husband checked base and confirms the bases are not strapped together with the bed link kit.Mrs.(b)(6) is 4 foot 11 inches and weighs about (b)(6) pounds.

• Brand Name: CRAFTMATICE 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 Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 7173942
• MDR Text Key: 96697354
• Report Number: 3008872045-2018-00003
• 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: Patient
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4AT056
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2017
• 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: 159