MAUDE Adverse Event Report: UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

This report is report is being filed under exemption (b)(4) by (b)(6) (registration #(b)(4)) on behalf of the importer (b)(4)).Enclosed is our information for a combined initial and final medwatch report, form 3500a.We are reporting this incident to ensure that we fully comply with medwatch reporting requirements.(b)(4) has received an information about a reportable event on the product which was not manufactured or imported by (b)(4).We are forwarding the information about this adverse event following the regulation under 21 c.F.R 803.22.2(b).Please note that despite out best effort (b)(4) did not manage to identify the original manufacturer nor a brand name of involved device.

Event Description

Arjohuntleigh was informed about an incident which occurred on a non-arjohuntleigh device.A female patient with multiple sclerosis, who was a wheelchair user has slipped in a bathtub, despite the help of two caregivers supporting her.The event took place at the nursing home.The patient has a cerebral palsy on one entire side of the body.As a result she suffered from a leg fracture which had to be followed by the surgery at (b)(6) hospital which took place on (b)(6) 2016.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 16645444
• MDR Report Key: 6282949
• MDR Text Key: 65958444
• Report Number: 3007420694-2017-00020
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2017

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: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2017
• Distributor Facility Aware Date: 12/29/2016
• Event Location: Nursing Home
• Initial Date Manufacturer Received: 12/29/2016
• Initial Date FDA Received: 01/27/2017
• Type of Device Usage: N
• Patient Sequence Number: 1