MAUDE Adverse Event Report: PRISM MEDICAL ADJUSTABLE LANYARD

Model Number 374682

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

Patient Problem Fall (1848)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

The pt's daughter was lifting him off his reclining chair.When he was 3" off the chair, the extension strap used with a p440 broke.

Manufacturer Narrative

We checked in-stock components of the adjustable lanyard (374682) and did not find the components to be out of specification nor sharp enough to reasonably cause such fraying of the strap.The adjustable lanyard is being returned on rga 16928.After it has been evaluated, we will reply with more descriptive codes and analysis.

• Brand Name: ADJUSTABLE LANYARD
• Type of Device: ADJUSTABLE LANYARD
• Manufacturer (Section D): PRISM MEDICAL; maryland heights MO
• Manufacturer Contact: jeff matthews ; 10888 metro ct; maryland heights, MO 63043 ; 3146929135
• MDR Report Key: 4232272
• MDR Text Key: 16303046
• Report Number: 3007802293-2014-00028
• 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,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/21/2014

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: Lay User/Patient
• Device Model Number: 374682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Unknown
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2013
• 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 Age: 65 YR
• Patient Weight: 159