MAUDE Adverse Event Report: MEDCARE PRODUCTS SCALE HANGER ASSEMBLY

Model Number 400600

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem Hip Fracture (2349)

Event Date 04/09/2015

Event Type  Injury  

Event Description

A scale hanger assembly in daily use since 2006 was reported as having the load cell end rod fail by coming apart.It was reported at the time of failure, a patient was being transferred from a wheel chair to the bed by a staff member of the facility and while doing so the patient fell approximately one foot and sustained a fractured left hip.

Manufacturer Narrative

At this time medcare products is unable to seek or provide additional details confirming this event and stated outcome due to the involvement of legal counsel sought by lexington health care of (b)(6).Therefore, any future correspondence on this matter will be addressed through prism medical legal representation.

• Brand Name: SCALE HANGER ASSEMBLY
• Type of Device: NI
• Manufacturer (Section D): MEDCARE PRODUCTS; burnsville MN 55337
• Manufacturer Contact: jeff matthews ; 151 cliff rd e; burnsville, MN 55337 ; 3146929135
• MDR Report Key: 4766601
• MDR Text Key: 5951423
• Report Number: 3007802293-2015-00013
• Device Sequence Number: 1
• Product Code: FSA
• 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: Other
• Type of Report: Initial
• Report Date: 05/06/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 400600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2015
• Initial Date FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDCARE LIFT.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 99