MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC

Model Number BRD100R

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

Patient Problems Micturition Urgency (1871); High Blood Pressure/ Hypertension (1908); Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475); Ascites (2596); Dyspareunia (4505); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.The alleged event is most likely associated with possible procedural/surgical complications.The ifu currently addresses potential risks associated with surgically implantable materials which states the following: precautions the usual precautions associated with urological procedures should be followed: accepted surgical practice and precautions must be followed for the management of contaminated or infected wound sites, when the align® urethral support system is used.Postoperative retropubic bleeding may occur in some patients and must be controlled prior to patient release.The implant procedure requires diligent attention to anatomical structure and care to avoid puncture of large vessels, nerves, bladder, and any viscera, during introducer needle passage.Cystoscopy should be performed to confirm bladder integrity or recognize a bladder perforation.Proper placement of the mesh sling implant at mid-urethra requires that it lies flat with minimal or no tension under the urethra.The align® urethral support system is intended as a single-use, disposable device.Do not resterilize any portion of the align® urethral support system.Patients should be advised that pregnancy following a mesh sling implant procedure may negatively affect the success of the previous implant procedure and incontinence may reoccur.The safety and effectiveness of the align® urethral support system implant procedure has not been established for the treatment of stress urinary incontinence in males or children under the age of 18.Do not use the align® urethral support system if the packaging is opened or damaged.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Post-operatively the patient is recommended to refrain from heavy lifting and/or exercise (i.E.Cycling, jogging) for at least three to four weeks and intercourse for one month.Adverse events complications associated with the proper implantation of the align® urethral support system may include, but are not limited to: postoperative hematoma, which may occur following the implant procedure.Temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the mesh sling implant.Perforations or lacerations of vessels, nerves, bladder or any viscera, which may occur during introducer needle passage transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion of the implant.2120, 2119 = "l", 2348, 1994, 2371, 2146, 1928, 2475= "nl".

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment.Per additional information received via medical records on (b)(6) 2022, the patient has experienced chronic recurrent urinary tract infections, painful sexual intercourse, difficulty in emptying bladder, partial urinary retention, occasional difficulty initiating voiding, vaginal burning and burning sensation when urinating, difficulty holding urine, dyspareunia, enterocele, rectocele, urinary incontinence, urinary retention, uterine prolapse and required additional surgical and non-surgical interventions.

Event Description

As per additional information received via medical records on 17-jan-2024, the patient had experienced recurrent urinary tract infections, painful sexual intercourse, difficulty emptying bladder, partial urinary retention, vaginal burning sensation when urinating, chronic constipation, dyspareunia, enterocele, hypertension, rectocele, recurrent or chronic vaginal or bladder infections, recurrent vaginal pain, urinary incontinence, urinary urgency and required additional surgical and non - surgical treatment.

Manufacturer Narrative

1908,1871,3274= "nl" h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
• Type of Device: ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 14278805
• MDR Text Key: 290662670
• Report Number: 1018233-2022-90016
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 00801741016172
• UDI-Public: (01)00801741016172
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Model Number: BRD100R
• Device Catalogue Number: BRD100R
• Device Lot Number: HUTA2004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2009
• 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
• Treatment: COLOPLAST NOVA SILK POLYPROPYLENE MESH
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 57 KG