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

Model Number 4AR791

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2018

Event Type  Injury  

Manufacturer Narrative

Sent customer a cage nut that was delivered on 3/30/2018.On 4/13/2018 (b)(6) technician installed the cage nut thus allowing him to screw the leg back into the base.On april 26, 2018, customer confirmed with (b)(6) that service was completed and is satisfied.

Event Description

Spoke to (b)(6), she states her (b)(6) mother was getting up, the bed tilted and they discovered a leg under the bed on saturday, (b)(6) 2018.The customer states that her nephew put a block under that side of the bed where the leg fell off in the meantime.The customer states that her mom weighs (b)(6) pounds.Customer confirms that her mother was not injured and did not need medical attention.

• 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: 7901706
• MDR Text Key: 121462870
• Report Number: 3008872045-2018-00012
• 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: Repair
• Type of Report: Initial
• Report Date: 09/20/2018

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: 4AR791
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 09/24/2018
• 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): Required Intervention
• Patient Age: 100 YR
• Patient Weight: 58