MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY TRACTION BOOT; ACCESSORY TO TABLE

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that during a patient procedure, the loop of the traction boot came off while the patient's foot was in the boot.No injuries or procedural delays or cancellations were reported.

Manufacturer Narrative

The user facility is using a steris traction boot with a non-steris traction device.The steris account manager stated that the user facility would like to return the traction boot for a credit as it was not satisfying their needs with their traction device (non-steris).The user facility prefers another style boot.No issues were noted with the traction boot subject of the reported event.The user facility was provided credit and the traction boot was returned to steris.

• Brand Name: TRACTION BOOT
• Type of Device: ACCESSORY TO TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4210870
• MDR Text Key: 4967824
• Report Number: 1043572-2014-00109
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2014
• 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): Other