MAUDE Adverse Event Report: HANDICARE AB RETURN 7500I; AID,TRANSFER

Model Number 7500I

Device Problems Fracture (1260); Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349); Patient Problem/Medical Problem (2688)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Outcome of investigation pending.A final report will be submitted upon completion.

Event Description

Patient slipped from the base plate on a 7500i return transfer system.The patient sustained a hip fracture.

Manufacturer Narrative

The internal investigation indicates that the event was most likely caused by either of the following: 1.Device leg supports mounted at wrong height, or 2.Adjustment pins of leg supports not correctly secured before use the user manual contains instructions on how to mount the device leg supports in relation to the patient's knee height and to ensure that adjustment pins are locked into position.Handicare ab sees no reason for further actions, but will continue to monitor this type of event.

• Brand Name: RETURN 7500I
• Type of Device: AID,TRANSFER
• Manufacturer (Section D): HANDICARE AB; sweden; torshamnsgatan 35; kista, VELES 140; MK VELES 1400
• MDR Report Key: 7180561
• MDR Text Key: 96933092
• Report Number: 3007802293-2018-00002
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7500I
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/11/2017
• Event Location: Nursing Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization