MAUDE Adverse Event Report: BARD PUERTO RICO TEGRESS URETHRAL IMPLANT

Catalog Number 653001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Event Description

Per additional information received, the patient has experienced stress urinary incontinence (sui), unspecified pain, unspecified infection, unspecified bowel problems, unspecified recurrence, and dyspareunia.

Manufacturer Narrative

The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.(b)(4).

• Brand Name: TEGRESS URETHRAL IMPLANT
• Manufacturer (Section D): BARD PUERTO RICO; las piedras PR
• Manufacturer (Section G): BARD PUERTO RICO; las piedras industrial park, lot #5; po box 2001; las piedras PR 00671
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 3940393
• MDR Text Key: 4572521
• Report Number: 1018233-2014-00155
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2008
• Device Catalogue Number: 653001
• Device Lot Number: 43KPH001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2005
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR