MAUDE Adverse Event Report: BARD STATLOCK UNIVERSAL PLUS STABILIZATION DEVICE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 02/20/2017

Event Type  Injury  

Event Description

Bilateral nephrostomy tubes placed with a statlock universal plus stabilization device by bard which was attached to both nephrostomy tubes which caused stage 2-3 bilateral pressure injuries.This product is marketed for this purpose.There was no literature or warning on their website re: pressure injuries.

• Brand Name: STATLOCK UNIVERSAL PLUS STABILIZATION DEVICE
• Type of Device: STABILIZATION DEVICE
• Manufacturer (Section D): BARD
• MDR Report Key: 6575585
• MDR Text Key: 75536669
• Report Number: MW5069841
• Device Sequence Number: 1
• Product Code: EYJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR