MAUDE Adverse Event Report: TELEFLEX INCORPORATED UROLIFT; IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM

Model Number IPN055826

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 02/07/2020

Event Type  malfunction  

Event Description

Hair found in sterile package prior to opening the device.Not used on a patient or ever opened the device package.Manufacturer response for urology device, urolift system (per site reporter) called the rep to inform him of the situation.He will replace the device with one that does not have a hair in it.

• Brand Name: UROLIFT
• Type of Device: IMPLANTABLE TRANSPROSTATIC TISSUE RETRACTOR SYSTEM
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 9693211
• MDR Text Key: 178573472
• Report Number: 9693211
• Device Sequence Number: 1
• Product Code: PEW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN055826
• Device Catalogue Number: UL400-4
• Device Lot Number: P42721
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36135 DA
• Patient Weight: 149