MAUDE Adverse Event Report: PRISM MEDICAL ADJUSTABLE LANYARD 12"-16"

Model Number 374681

Device Problems Material Frayed (1262); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

Patient was suspended in a sling being transferred into a wheelchair.The adjustable lanyard's strap tore and the patient fell into a wheelchair.The portable lift also fell, striking an aide worker.

Manufacturer Narrative

This incident occurred on (b)(6), 2014, and prism medical was notified on dec 10, 2014.The lanyard was received on dec 15, 2014.Investigation is underway.Upon completion of investigation, a report with more descriptive codes will be provided.

• Brand Name: ADJUSTABLE LANYARD 12"-16"
• Type of Device: ADJUSTABLE LANYARD 12"-16"
• Manufacturer (Section D): PRISM MEDICAL; maryland heights MO
• Manufacturer Contact: jeff matthews ; 10888 metro ct.; maryland heights, MO 63043 ; 3146929135
• MDR Report Key: 4379754
• MDR Text Key: 5238067
• Report Number: 3007802293-2014-00032
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 374681
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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