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 Laceration(s) (1946); Injury (2348)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2018, ordered customer a replacement dual density mattress (order # (b)(6)).Delivery date of replacement mattress has not yet been scheduled.A follow up submission to the fda will be made when additional information becomes available.

Event Description

Customer states she was changing sheets on the bed and cut her hand.She states she cut her hand on a wire that was sticking out of the top of the mattress.Customer states the incident occurred a couple of weeks ago on or around the (b)(6) 2018 while putting on clean sheets on her bed which customer confirmed she does every monday (customer could not confirm actual date).Customer confirmed she was not seriously injured and did not seek medical treatment, she put a band aid on the wound.

• 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; 5192 sw 27th ave; fort lauderdale FL 33312
• Manufacturer Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 7804305
• MDR Text Key: 117834806
• Report Number: 3008872045-2018-00009
• 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: 08/08/2008

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: M1242-07
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/22/2018
• 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
• Patient Weight: 66