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 Adhesion(s) (1695); Autoimmune Disorder (1732); Diarrhea (1811); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Hernia (2240); Injury (2348); Abdominal Cramps (2543); Constipation (3274); Dyspareunia (4505); 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

The patient's attorney alleged a deficiency against the device.

Manufacturer Narrative

1994, 2123, 1928= "l" 1695, 3274, 1811, 2240= "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.

Event Description

Per additional information received via medical records on 11apr2022, the patient has experienced vaginal pain, mesh exposure, dyspareunia, vaginal pressure, vaginal/abdominal cramping, vaginal discharge/bleeding, pelvic pain, pelvic floor dysfunction, recurrent stress urinary incontinence, adhesions, chronic constipation, crohn's disease, irritable bowel syndrome, ulcerative colotis or chronic diarrhea, diverticulitis, dyspareunia, hernias, recurrent vaginal pain, urinary incontinence, and required additional surgical and non-surgical interventions.

Event Description

As per additional information received via medical records on 17-jan-2024, the patient had experienced vaginal exposure of mesh sling and vaginal pain, dyspareunia, vaginal pressure, vaginal/abdominal cramping, abnormal vaginal discharge/bleeding, pelvic pain, pelvic muscle spasms, knee infection, pelvic floor dysfunction, recurrent stress urinary incontinence and an autoimmune response, adhesions, chronic constipation, crohn¿s disease, irritable bowel syndrome, ulcerative colitis, diverticulitis, dyspareunia, recurrent vaginal pain, stress urinary incontinence, blood clot in left leg, bilateral swelling, lower limb edema, calf pain and required additional surgical and non-surgical treatments.

Manufacturer Narrative

1930 = "l".2543, 1966, 1733, 2091= "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® 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: 9507251
• MDR Text Key: 178590148
• Report Number: 1018233-2019-08168
• 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
• Report Date: 02/09/2024

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: 09/30/2014
• Device Model Number: BRD200S
• Device Catalogue Number: BRD200S
• Device Lot Number: HUWH0343
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 14 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 04/11/2022; 01/17/2024
• Supplement Dates FDA Received: 05/04/2022; 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2012
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 73 KG