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

Model Number BRD300RS

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

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Injury (2348); Deformity/ Disfigurement (2360); Disability (2371); Obstruction/Occlusion (2422); Skin Tears (2516); Dysuria (2684); Dyspareunia (4505)

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, 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

T 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: g1.2119, 2120, 1930 = l.1685,1811, 1695, 1928, 2519, 2564 = "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 urinary retention, urinary tract infections, difficulty voiding, dyspareunia, pelvic pain, vaginal pain and abdominal pain, psychological stress, adhesions, crohn's disease, irritable bowel syndrome, ulcerative colitis or chronic diarrhea, recurrent or chronic vaginal or bladder infections, urinary incontinence and required additional surgical and non-surgical interventions.

Manufacturer Narrative

2422, 2061, 2516, 2275, 2684= "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

As per additional information received via medical records on 17jan2024, the patient experienced urinary retention, urethral obstruction, constant urinary tract infections, bladder, pelvic and vaginal pain, severe scarring, difficulty in sexual intercourse, difficulty voiding, dyspareunia, thin skin tears, abdominal pain, psychological stress, dry eyes, dry skin, adhesions, ulcerative crohn¿s disease, bladder and bacterial infection, urinary incontinence, urethral stricture, urinary frequency, dysuria, urethral dilation and required additional surgical and non-surgical treatments.

• Brand Name: ALIGN® RS URETHRAL SUPPORT SYSTEM
• Type of Device: ALIGN® RS URETHRAL SUPPORT SYSTEM
• 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: 9309432
• MDR Text Key: 165974684
• Report Number: 1018233-2019-07232
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00801741016196
• UDI-Public: (01)00801741016196
• 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: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: BRD300RS
• Device Catalogue Number: BRD300RS
• Device Lot Number: HUTD1799
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 7 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2009
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White