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

Model Number	BRD400HK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750); Chest Pain (1776); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Prolapse (2475); Foreign Body In Patient (2687); Dyspareunia (4505); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional 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® to urethral support system is used.Postoperative 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.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® to urethral support system is intended as a single-use, disposable device.Do not resterilize any portion of the align® to 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® to urethral support system implant procedure has not been established for the treatment of stress urinary incontinence in males and children under the age of 18.Cystoscopy can be considered at the physician¿s discretion.Do not use the align® to 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® to 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.
Event or Problem Description
This complaint is being opened in association with the alleged event filed by the patient¿s attorney in complaint number(s) (b)(4).There have been no allegations of deficiency or serious injury against this device.This device is listed in the patient¿s medical record.It was reported in the patient¿s medical records received on november 19, 2018, that as a result of having the product implanted, the patient has experienced graft exposure (foreign body in patient), dyspareunia, vaginal bleeding (blood loss), erosion, post-coital bleeding, urinary frequency, defect, cessation of coitus, urinary tract infection, scarring (scar tissue), nonsurgical and additional surgical interventions.Per additional information received on 20jul2021, the patient experienced severe pain, vaginal bleeding, painful sexual intercourse, mesh erosion, cystocele, recurrent vaginal yeast infections, recurrent vaginal pain, urinary incontinence, urinary retention, uterine prolapse, vaginal vault prolapse, dyspareunia, vaginal graft exposure, urinary frequency, urinary tract infection, breast pain and required additional surgical and non-surgical interventions.
Additional Manufacturer Narrative
2120, 2687, ="l".2060, 2519, 2597, 2348, 2475, 3191="nl".H11: section a through f - the information provided by bard 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 bard.
Event or Problem Description
Per additional information received via medical records on 03jan2024, the patient experienced severe pain, pelvic pain, vaginal mesh erosion, mesh exposure, vaginal bleeding, painful sexual intercourse, cystocele, recurrent or chronic vaginal or bladder infections, recurrent vaginal pain (sharp pains that feel like bad menstrual cramps, in the lower abdomen), urinary incontinence, urinary retention, uterine prolapse, vaginal vault prolapse, wound healing problems, collapsed bladder requiring additional surgical and non-surgical treatments.

• Brand Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK
• Common Device Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK
• 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: 12272078
• Report Number: 1018233-2021-80054
• Device Sequence Number: 14803284
• Product Code: OTN
• UDI-Device Identifier: 00801741016219
• UDI-Public: (01)00801741016219
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2012
• Device Model Number: BRD400HK
• Device Catalogue Number: BRD400HK
• Device Lot Number: HUUA0184
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AVAULTA PLUS® BIOSYNTHETIC ANTERIOR; AVAULTA PLUS® BIOSYNTHETIC ANTERIOR; AVAULTA PLUS® BIOSYNTHETIC ANTERIOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 82 KG