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

Model Number	BRD500HL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); High Blood Pressure/ Hypertension (1908); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Anxiety (2328); Discomfort (2330); Prolapse (2475); Abdominal Cramps (2543); Intermenstrual Bleeding (2665); Dyspareunia (4505); Urinary Incontinence (4572)
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.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.1750="l"; 1928, 2475, 2993="nl".
Event or Problem Description
The patient's attorney alleged a deficiency against the device.Per additional information received via medical records on 15oct2021, the patient has experienced stress urinary incontinence, pelvic organ prolapse, cystocele, rectocele, vaginal pain, dryness, pelvic pain, mesh erosion, dyspareunia, extrusion, abdominal cramps, bloody vaginal discharge, urinary leakage, mixed incontinence, nocturia, enuresis, incomplete emptying of bladder, anxiety, hypertension, hypercholesterolemia, acute vaginitis, adhesions, metromenorrhagia, uterine fibroids, menstrual bleeding, dysmenorrhea, vaginal spotting, acute appendicitis, abdominal pain, nausea, discomfort, loss of appetite, diarrhea and required additional surgical and non-surgical interventions.

• Brand Name: ALIGN TO URETHRAL SUPPORT SYSTEM - HALO
• Common Device Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12703525
• Report Number: 1018233-2021-80082
• Device Sequence Number: 4613994
• Product Code: OTN
• UDI-Device Identifier: 00801741016226
• UDI-Public: (01)00801741016226
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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: 07/31/2008
• Device Model Number: BRD500HL
• Device Catalogue Number: BRD500HL
• Device Lot Number: CVRG0038
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR