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

Model Number BRD200S

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

Patient Problems Abdominal Pain (1685); Erosion (1750); Calcium Deposits/Calcification (1758); Erythema (1840); Fistula (1862); Flatus (1865); Foreign Body Reaction (1868); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Inflammation (1932); Pain (1994); Pelvic Inflammatory Disease (2000); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Distress (2329); Discomfort (2330); Injury (2348); Disability (2371); Numbness (2415); Dysuria (2684); Constipation (3274); Stomach Ulceration (4488); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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® urethral support system may include, but are not limited to: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding dysfunctions.These conditions may be associated with overcorrection/ too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, or any viscera, which may occur during the implantation procedure.Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.Extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.Inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of incontinence." (b)(4).

Event Description

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.

Manufacturer Narrative

Correction: mdr date of awareness.

Event Description

Per additional information received, the patient has experienced mesh penetrating in the posterior/dome of right side of bladder with inflammation, pelvic pressure, urinary tract infection, squeezing/spasming, dysuria, pain, bladder pain, fistula, bladder inflammation, foreign body reaction, low back pian, edema, erythema, calcification, incontinence, worsening abdominal pain, bladder stone, bladder spasms, lower abdominal pressure, difficulty walking due to discomfort, burning sensation when urinating and suffered emotional and mental distress, recurrent vaginal pain, urinary incontinence, pelvic pressure, urinary tract infection, abdomen feels tight with passing gas and cannot strain, chronic inflammation, mesh exposure, and urinary frequency.Additionally, the patient required surgical and non-surgical interventions.

Manufacturer Narrative

1750, 2000, 2120="l.".

Event Description

As per additional information received via medical records on 11jan2024, the patient had experienced mesh erosion, bladder calculus, urinary tract infections, incontinence, severe bladder pain, bladder spasms, discomfort, hypertension, recurrent or chronic vaginal or bladder infections, cellulitis, urge incontinence, urinary frequency, recurrent vaginal pain, emotional distress, pelvic pressure, erythema, ulceration, neoplasm of bladder, dysuria, constipation, bloating, joint pain, upper and lower denture throat, left thigh numbness, flatus passing and belching, abdominal pain, perineal pain, dysuria, urinary leakage, bladder inflammation and required additional surgical non-surgical treatment.

Manufacturer Narrative

1932, 1930, 1685, 2275 = "l" 1966, 2648, 1862, 1868.1820, 1840, 1928, 1758, 2146, 2564, 2519, 2330, 1908, 2116, 3274, 2355, 2415 1865 = "nl" correction: g.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® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC
• Type of Device: ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC
• 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: 10513795
• MDR Text Key: 206309475
• Report Number: 1018233-2020-05790
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00801741016189
• UDI-Public: (01)00801741016189
• 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,Followup,Followup
• Report Date: 02/06/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2009
• Device Model Number: BRD200S
• Device Catalogue Number: BRD200S
• Device Lot Number: HUSH1440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/29/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 11/10/2020; 01/11/2024
• Supplement Dates FDA Received: 09/24/2020; 12/02/2020; 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2008
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White