MAUDE Adverse Event Report: SAG PRODUCTS LLC SAGE PREVALON TAP SYSTEM; PREVALON TAP SYSTEM 2.0

Device Problems Accessory Incompatible (1004); Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 12/19/2018

Event Type  Injury  

Event Description

Through the process of conducting an investigation related to an adverse event, it has been noted that the sage prevalon tap system 2.0 is not compatible to be used in conjunction with the standard operating room wedge that is often used by anesthesia when pts are not able to tolerate lying flat.When the mat and the positioning wedge are placed against each other, they become extremely slippery and can lead to pt falls in the operating room.Cross-check of mfr recommendations do not alert users to this potential hazard as they, sage may not be aware.It is important to note that while this product was a contributing factor to the event it was not the direct cause.

• Brand Name: SAGE PREVALON TAP SYSTEM
• Type of Device: PREVALON TAP SYSTEM 2.0
• Manufacturer (Section D): SAG PRODUCTS LLC
• MDR Report Key: 8433441
• MDR Text Key: 139285846
• Report Number: 8433441
• Device Sequence Number: 1
• Product Code: KME
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2019
• Distributor Facility Aware Date: 12/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 78 YR
• Patient Weight: 127