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

Model Number 4A1378

Device Problem No Apparent Adverse Event (3189)

Patient Problem Fall (1848)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

Unique complaint id (b)(4).Recommended the customer contact invacare or a medical supply store.Informed the customer that we do not attach rails to the craftmatic beds.

Event Description

Customer was able to confirm the bed was purchased and delivered in 2005.Spoke to (b)(6), she states the side rail came unattached and rolled off: she states her husband rolled out of bed, twice 2 weeks ago.The customer states the rail was installed to remind her husband not to fall off the bed.Customer's husband suffers from a traumatic brain injury due to a truck accident.Customer's husband sustained bruising to his left hip area but confirms that medical attention or intervention was not needed.Customer's husband is 6 feet tall and weighs (b)(6) pounds.

• 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 Contact: jessica vivar ; 5192 sw 27th ave; fort lauderdale, FL 33312 ; 9548280893
• MDR Report Key: 7063394
• MDR Text Key: 93079935
• Report Number: 3008872045-2017-00041
• 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 Family Member or Friend
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/24/2017

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: 4A1378
• Device Catalogue Number: CMMOD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 11/28/2017
• 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: 118