MAUDE Adverse Event Report: C.R. BARD, INC. TEGRESS URETHRAL IMPLANT

Catalog Number 653001

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

Patient Problems Incontinence (1928); Urinary Tract Infection (2120); Hematuria (2558)

Event Type  Injury  

Event Description

The patient has experienced elevated postvoid residual (90 mls), recurrent stress urinary incontinence (positive marshall test), adhesions between anterior vaginal mucosa and bladder, urinary tract infection, nocturia, intrinsic sphincteric deficiency, "coaptation difficulty in getting good submucosal purchase" in the areas the physician anticipated were bound by the sling, "fair amount of prolapse," unspecified infection, significant smoker's cough, hematuria, external vaginal itching, exploratory laparotomy with lysis of adhesion, vaginal atrophy with scant discharge, nodular basal cell carcinoma of vulva, vulvar irritation/vulvitis, atrophic external genitalia, leg pain (related to peripheral arterial disease, claudication, and venous insufficiency) unspecified pain, unspecified erosion, unspecified urinary problems, unspecified recurrence, and unspecified bleeding.

Manufacturer Narrative

The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.(b)(4).

• Brand Name: TEGRESS URETHRAL IMPLANT
• Manufacturer (Section D): C.R. BARD, INC.; covington GA
• Manufacturer (Section G): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4234452
• MDR Text Key: 21996979
• Report Number: 1018233-2014-00292
• 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: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 653001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 71 YR