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

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

Patient Problems Pain (1994); Urinary Tract Infection (2120); Injury (2348)

Event Type  Injury  

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.The instructions for use states in the 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.(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received, the patient has experienced pain and urinary problems.Per additional information received, the patient has experienced chronic urinary tract infections, dyspareunia, malnutrition, pelvic trauma, vaginal pain, urinary retention, uterine prolapse, vaginal vault prolapse, and hernia(s), vulvar dystrophy.Diarrhea, recurrent dysuria, frequency, urgency, urinary incontinence, hesitancy, weak stream, vulvar lesion, vulvar discomfort and pruritus / redness discoloration of vulva, candidal infection, grade iii cystocele, colonic and sigmoid diverticulosis, chronic pelvic pain, vulvar pain, vague suprapubic abdominal and back pain, scar below urethra, enterocele, burning on urination, pain radiating from pelvis to back, overactive bladder, intermittency, sense of incomplete emptying of the bladder, pelvic pain, neurogenic bladder, depression, insomnia, anxiety, exploratory abdominal surgery, adhesions, colon surgery, atrophic vaginitis, chronic constipation, urine culture positive for staphylococcus lugdunensis; right upper quadrant pain, with diagnosis of rhabdomyolysis.Per additional information received, the patient has experienced urinary tract infection, incomplete difficult emptying, pelvic pain, foreign body in patient, pain, elevated urinary residual, urinary retention, bladder trabeculations, inflammation, restrictive/obstructive urinary issues, tightened introitus, edema, bladder puncture, nonsurgical and additional surgical interventions.Per additional information received, the patient has experienced emotional distress, severe pelvic pain, discomfort, chronic constipation, cystocele, diverticulitis, pelvic trauma, recurrent chronic vaginal and bladder infections, recurrent vaginal pain, vaginal discharge, dystrophy of vulva, abdominal pain left lower epigastric, urge incontinence, pelvic adhesions, recurring urinary tract infections, incomplete emptying.The patient required surgical and non-surgical interventions.

• Brand Name: ALIGN TO URETHRAL SUPPORT SYSTEM - HALO
• Type of Device: ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO
• 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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10896388
• MDR Text Key: 218251869
• Report Number: 1018233-2020-06361
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00801741016226
• UDI-Public: (01)00801741016226
• 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
• Report Date: 11/24/2020

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: 06/30/2009
• Device Model Number: BRD500HL
• Device Catalogue Number: BRD500HL
• Device Lot Number: HUSF0183
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2008
• 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: 72 YR
• Patient Weight: 84