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

Model Number BRD500HL

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

Patient Problems Unspecified Infection (1930); Pain (1994); 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(r) 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, infection, urinary problems, recurrence, bleeding, dyspareunia, and vaginal scarring.Per additional information received, the patient has experienced pelvic pain, infection, urinary problems, recurrence of incontinence, vaginal bleeding, dyspareunia, vaginal scarring, urethral obstruction, bowel problems, recurrent urinary tract infections, nerve damage in lower left side, tingling and numbness, adhesions, chronic constipation, depression, pelvic floor physical therapy, trigger point injections, obesity, peritonitis/sepsis, recurrent vaginal pain, left lower quadrant abdominal pain, hematuria, dysuria, urge incontinence, severe pelvic pain, urge incontinence, nocturia, hesitancy, intermittency, straining to void, sensation of incomplete emptying, need to re-void, position-dependent voiding, straining to defecate, sensation of incomplete bowel emptying, hypertonicity of bladder, overactive bladder, tenderness medial to iliopsoas tendon left greater than right, rectal bleeding, cystitis, vestibulodynia, pelvic floor muscle spasm, slow urination, pain on right between hip and pelvis, cyst on right lobe of liver, detrusor instability, granulation tissue with silver nitrate application, vaginal bleeding, voiding dysfunction, frequency, suprapubic pain, passing blood clots after intercourse, hydrosalpinx, chronic bladder inflammation, vaginal discharge with odor, and levator hypertonus.She required both surgical and nonsurgical interventions.Per additional information received, the patient has experienced pain, unexplained bleeding, pain during sex, no longer engage in sex, muscle spasms, pelvic floor therapy, unable to move, partial removal, protruding mesh through vaginal wall, infections, urinary tract infections, odor, pudendal nerve block, posture orthostatic tachycardia syndrome, autoimmune deficiencies, nerve damage, loss of quality of life, infections, vaginal scarring, numbness, tingling, sharp stabbing pain, weak reflexes, pain when walking, unable to drive, pulmonary problems, depression, suicide attempts, prescription medicine, bowel/gastrointestinal dysfunctions, gastroparesis, malnourished and disability.Per additional information received, the patient has experienced vaginal scarring, mesh erosion, mesh exposure, unable to hold urine, scar tissue, leaking urine, urinary urgency, nocturia, frequency, straining on urination, acute cystitis with hematuria, depression, hives, rectal bleeding, postoperative nausea and vomiting, menometrorrhagia causing anemia, dysmenorrhea, dyspareunia, myomatous uterus, and genuine urinary stress incontinence, trauma.Additionally, the patient required 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: 11073790
• MDR Text Key: 223713501
• Report Number: 1018233-2020-06393
• 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: 12/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2009
• Device Model Number: BRD500HL
• Device Catalogue Number: BRD500HL
• Device Lot Number: HUSD0716
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2008
• 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: 42 YR
• Patient Weight: 103