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

Model Number 4AR790

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sprain (2083); Thrombosis (2100)

Event Date 03/17/2017

Event Type  Injury  

Manufacturer Narrative

The complainant requested a replacement mattress.At the time of purchase it was explained to the customer that a single king size mattress would be the best fit for her weight.The complainant insisted on a dual system bed.No known defect was established per complainant other than comfort.Craftmatic industries will replace the two twin mattresses with one king size mattress, the bed bases are to be linked to one remote for use.Customer keeping device, no known defect.

Event Description

Complainant purchased two twin mattresses as well as two twin bases on (b)(6) 2016, the product was delivered 4/11/2016.Complainant states that on the evening of (b)(6) 2017 while sleeping on her bed the mattresses separated causing her to get her shoulder stuck in between both twin mattresses.Complainant states that due to comfort issues she "tosses and turns" in the mattress throughout the night.Complainant states that she sprained her left shoulder because she her shoulder was stuck in between the mattresses.The complainant states on (b)(6) 2017, she went to the emergency room at (b)(6).Complainant confirms that she was not admitted to the hospital but was told she sprained her left shoulder and that a blood clot had formed in her left shoulder.Complainant was prescribed pain medication.Complainant states she has a follow up appointment (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.; 7411 fisher island drive; miami beach FL 33019 0700
• Manufacturer (Section G): CRAFTMATIC INDUSTRIES, INC.; 7411 fisher island drive; miami beach FL 33019 0700
• Manufacturer Contact: jessica vivar ; 7411 fisher island drive; miami beach, FL 33019-0700 ; 9548280893
• MDR Report Key: 6513339
• MDR Text Key: 73458383
• Report Number: 3008872045-2017-00008
• 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: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4AR790
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/21/2017
• 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; Required Intervention
• Patient Weight: 178