MAUDE Adverse Event Report: CRAFTMATIC INDUSTRIES, INC CRAFTMATIC MODEL1 BASE; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number 4AT056

Device Problem Temperature Problem (3022)

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

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer forwarded pictures regarding the complaint, though the cause can not be confirmed without an investigation; the fabric surrounding the metal piece appears to have burn marks.The base will be returned to leggett and platt for a thorough investigation and root cause.Base will be replaced per (b)(4).Based on the information provided by the customer; the complaint is reportable per cfr 21 803.3.Mdr 2018-00008.Customer was shipped a 39x80 legacy base that was delivered on (b)(6) 2019.On (b)(6) 2019 the customer, (b)(6) confirmed delivery.No further assistance is required.

Event Description

Mrs.(b)(6) called in to advise there is a piece of metal sticking out of the base.Customer states something is coming thru the base cover.Husband removed the mattress and found a hole about 1 to 2 feet from end of bed.The metal piece is black.Customer uses the foot massage several times a day, the issue is on her base.When massage motor turns off, the customer waits about 1 to 2 hours before turning it on again.The customer confirmed that no medical attention was not needed and no injuries were sustained.Customer does not believe the mattress is affected.Advised the customer to discontinue the use of the foot massage any longer.

• Brand Name: CRAFTMATIC MODEL1 BASE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC INDUSTRIES, INC; 5192 sw 27th ave; ft. 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 ; 9548280893
• MDR Report Key: 8816849
• MDR Text Key: 151895859
• Report Number: 3008872045-2019-00008
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4AT056
• Device Catalogue Number: CMMOD1
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/23/2019
• 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): Other