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

Model Number M1242-07

Device Problems Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)

Patient Problems Abrasion (1689); Injury (2348)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

Unique id :(b)(4).Ordered customer a replacement 39x80 dual density mattress, per order number (b)(4).Placing the mattress on a delivery hold, customer will be out of town thru (b)(6) 2018.Once customer is ready for delivery, customer has agreed to call when ready to schedule delivery - a new ticket will be opened at that time.

Event Description

Spoke to (b)(6).Customer claims that he was changing sheets on his mattress on (b)(6) 2018 and discovered a protruding spring that scratched his hand.Customer scratched his right hand, he thinks.He stated that he is fine and stated that "it was just a little scratch".Customer confirms that no medial attention was needed.

• 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 (Section G): CRAFTMATIC INDUSTRIES, INC; 3580 gateway drive; pompano beach FL 33069
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 8202444
• MDR Text Key: 131600287
• Report Number: 3008872045-2018-00014
• 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: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M1242-07
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2018
• 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