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

Model Number 4AR794

Device Problem Temperature Problem (3022)

Patient Problem Missing Value Reason (3192)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Unique id (b)(6).Contacted customer on (b)(6) 2019 and stated he received his bed in which is very happy of the customer service.His bed is working smooth and the delivery team removed his old bed.The customer requires no further assistance.Base is being returned to leggett and platt for investigation.A follow up submission will be sent to the fda once results are available.

Event Description

Customer called on (b)(6) 2019, customer claims he has a hole on the base.

• 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 ; 9548280893
• MDR Report Key: 9650028
• MDR Text Key: 191830853
• Report Number: 3008872045-2020-00002
• 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: 01/30/2020

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: 4AR794
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 01/30/2020
• 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): Other