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

Model Number 4AT057

Device Problem Insufficient Information (3190)

Patient Problem Electric Shock (2554)

Event Date 12/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).On 1/9/2017, per management base will be replaced.Base is scheduled to deliver to the customer by 2/3/2018.Alleged defective base will be picked up at that time and will be returned to leggett and platt (manufacturer of base) for a thorough investigation.Due to pending investigation results, a follow up submission to the fda will be submitted when the investigation results are available.

Event Description

Spoke to (b)(6).Customer was laying in bed, she was elevating her head and then got shocked in the back of her leg and her back.Then the bed stopped working.Customer stated that she has metal in her back and knee.Customer is okay and did not seek medical treatment.Incident occurred on (b)(6) 2017.

• 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 Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 7205610
• MDR Text Key: 97742976
• Report Number: 3008872045-2018-00005
• 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: Replace
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: 4AT057
• 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: 12/18/2017
• 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