MAUDE Adverse Event Report: PRISM MEDICAL ADJUSTABLE LANYARD

Model Number 374681

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Bruise/Contusion (1754); Fall (1848); Injury (2348)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

Outcome of investigation is pending receipt of unit to evaluate.A final report will be submitted upon completion.

Event Description

Individual was moving from the toilet when the lanyard broke.He fell to the ground in his bathroom, landing on his side and back.He went to the doctor.His ribs were bruised.

Manufacturer Narrative

The lanyard was received via rga (b)(4) and inspected.The lanyard was purchased in (b)(6) 2012 and is 4 years old.The returned strap has clear wear and tear in the form of frayed straps.There were no sharp edges, burrs, or defects found on the buckle or metal d-ring.Fray patterns seen were extensive and easily identified as a risk of separation.Wear and tear of component parts and accessories occurs naturally during normal use.Accordingly, parts and accessories must be routinely inspected, maintained, and replaced.The user is require to visually inspect the lift, its components and accessories prior to use to evaluate whether the lift is safe to use or whether certain components and/or accessories should be replaced.The p440 lift user manual, for the lift and all accessories, specifies the frequency of visual checks before each use monthly and semi-annually.Root cause: lack of pre-use, monthly, semi-annual inspection prior to use.Corrective action: highlighted the need for customer to perform frequent inspections on all lifting equipment and accessories to ensure good working order.

• Brand Name: ADJUSTABLE LANYARD
• Type of Device: LANYARD
• Manufacturer (Section D): PRISM MEDICAL; 10888 metro court; maryland heights MO 63043
• Manufacturer (Section G): PRISM MEDICAL; 10888 metro court; maryland heights MO 63043
• Manufacturer Contact: steve kilburn ; 10888 metro court; maryland heights, MO 63043 ; 3142198614
• MDR Report Key: 5554139
• MDR Text Key: 42622687
• Report Number: 3007802293-2016-00056
• 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: consumer,distributor
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 374681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Weight: 127