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

Model Number 4AM663

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 12/24/2016

Event Type  Injury  

Manufacturer Narrative

Complaint id, (b)(6).The part is currently in transit for investigation an update will be submitted to the fda upon receipt of the results.

Event Description

Complainant states that while he was in a sitting position in his bed, as he lowered his bed, the left rear leg snapped and he fell.The complainant states he hit his head and had to go to the emergency room on (b)(6) 2016.He said he received several stitches above his right eye.

• Brand Name: CRAFTMATICE 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 33141 ; 9548280893
• MDR Report Key: 6357642
• MDR Text Key: 68292228
• Report Number: 3008872045-2017-00001
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K22387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 12/30/2016

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: 4AM663
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 02/24/2017
• 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): Hospitalization