MAUDE Adverse Event Report: H. FINE & SONS LTD COMMODE SLING WITH CHAINS; SLING FOR A LIFT

Model Number 113-D

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 06/07/2015

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, the patient was being moved from bed to chair when the sling tipped and chain came off the cradle hook, dropping the patient;.The patient's head hit the bar on the way down and she landed on her head.The patient was taken to the hospital where a ct scan was done and a c2 fracture was found.The patient also received 4 stitches above left eyebrow and 1 stitch on yop of here head.Complaint #(b)(4) were entered into our system to have the sling and lift returned to joerns for investigation.As of this writing, the sling and lift have not been returned.

Manufacturer Narrative

Joerns sending the report to the manufacturer.

• Brand Name: COMMODE SLING WITH CHAINS
• Type of Device: SLING FOR A LIFT
• Manufacturer (Section D): H. FINE & SONS LTD; london ; UK
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014 ; 8008260270
• MDR Report Key: 4863024
• MDR Text Key: 5866968
• Report Number: 3009402404-2015-00017
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/18/2015

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: Health Professional
• Device Model Number: 113-D
• Device Catalogue Number: 113-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2015
• Distributor Facility Aware Date: 06/07/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/18/2015
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 06/19/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR
• Patient Weight: 54