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 Adhesion(s) (1695); Diarrhea (1811); Fatigue (1849); Micturition Urgency (1871); Incontinence (1928); Muscle Weakness (1967); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Anxiety (2328); Injury (2348); Depression (2361); Hematuria (2558); Blood Loss (2597); Constipation (3274); Cramp(s) /Muscle Spasm(s) (4521)

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.Per additional information, the patient has experienced blood loss, incontinence, dysuria, dyspareunia, urinary tract infection, pain, inability to have intercourse, anxiety/depression, fatigue, incomplete bladder emptying, pelvic pain, pelvic floor dysfunction, sexual dysfunction, spastic pelvic floor syndrome (muscle spasm), urethral instability, urinary urgency, urinary frequency, inability to void, vulvodynia, cramping, interstitial cystitis, bladder pressure/pain, diarrhea, constipation, tenderness, blood in urine, nonsurgical and additional surgical interventions.It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, injury, disability, and impairment.

Event Description

Per additional information received via medical records on 11apr2022, the patient has experienced bladder pain syndrome and dyspareunia caused by complications of mid urethral sling, adhesions, stress incontinence, dysuria, dyspareunia, pelvic pain, incomplete bladder emptying, urgency of urination, urethral instability, pelvic floor dysfunction, spastic pelvic floor dysfunction, painful chronic bladder pain, psychological, mental, and emotional injuries, urgency, neuromuscular disease or disorder, rectocele, recurrent or chronic vaginal or bladder infections, recurrent vaginal pain and required additional surgical and non-surgical interventions.

Manufacturer Narrative

2120, 2275, 2119, 1930= "l".2684, 1994, 2328, 2361, 1849, 1966, 1871, 2193, 1811, 3274, 2371, 1695= "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® 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: 10804492
• MDR Text Key: 215280580
• Report Number: 1018233-2020-06341
• 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,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2012
• Device Model Number: BRD500HL
• Device Catalogue Number: BRD500HL
• Device Lot Number: HUUF1341
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2010
• 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: UNK INTERCEED.; UNK INTERCEED.
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female