MAUDE Adverse Event Report: HILL-ROM HILL-ROM BURKE TRIFLEX 2 SCALE TRAPEIZE

Model Number P6877B

Device Problem Entrapment of Device (1212)

Patient Problems Laceration(s) (1946); Physical Entrapment (2327)

Event Date 07/18/2016

Event Type  Injury  

Event Description

Patient with frail skin caught left leg on the bed rail, which caused a laceration requiring stitches.

• Brand Name: HILL-ROM BURKE TRIFLEX 2 SCALE TRAPEIZE
• Type of Device: BURKE TRIFLEX 2 SCALE TRAPEIZE
• Manufacturer (Section D): HILL-ROM; chicago IL 60601
• MDR Report Key: 5821701
• MDR Text Key: 50527869
• Report Number: MW5063624
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P6877B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention