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

Model Number BRD100R

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

Patient Problems Abdominal Pain (1685); Hot Flashes/Flushes (2153); 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¿ 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.Per additional information received, the patient has experienced hot flashes, lower abdominal wall pain, incontinence is getting worse, urgency incontinence, musculoskeletal pain, scarring, stress urinary incontinence, hypomobility, left renal calculus, right flank abdomen pain, pelvic pain, nephrolithiasis, small polyp, intermittent chronic constipation, irritable bowel syndrome, fatty liver, suprapubic and deep pelvic bowel pain, frequency, right lower quadrant pain, urinary incontinence and incomplete emptying, pain mostly with movement, fecal incontinence, pelvic dyssynergia, abnormal liver function tests, diverticulosis of colon, abdominal pain, right lower quadrant, pain in female pelvis, situational anxiety.The patient required additional non-surgical interventions.

• Brand Name: ALIGN URETHRAL SUPPORT SYSTEM RETROPUBIC
• Type of Device: ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
• 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: 11073795
• MDR Text Key: 223713032
• Report Number: 1018233-2020-06394
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00801741016172
• UDI-Public: (01)00801741016172
• 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: 01/30/2011
• Device Model Number: BRD100R
• Device Catalogue Number: BRD100R
• Device Lot Number: HUTA0377
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2009
• 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: 41 YR
• Patient Weight: 85