MAUDE Adverse Event Report: INTEGRA PAIN MANAGEMENT CAUSAL EPIDURAL TRAY; 44 - TRAYS

Catalog Number 3403052

Device Problem Torn Material (3024)

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

Event Type  malfunction  

Event Description

Customer reports 5 trays that were torn in the same corner.

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: CAUSAL EPIDURAL TRAY
• Type of Device: 44 - TRAYS
• Manufacturer (Section D): INTEGRA PAIN MANAGEMENT; salt lake city UT 84104
• Manufacturer Contact: sandra lee ; 315 enterprise drive; 6099366828
• MDR Report Key: 3726466
• MDR Text Key: 20698231
• Report Number: 1722447-2014-00001
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3403052
• Device Lot Number: W1309257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1