MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 Align® TO Trans-Obturator Urethral Support System - Hook & Halo; ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO

Model Number BRD600HH

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Micturition Urgency (1871); Sepsis (2067); Depression (2361)

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

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, discomfort, urinary problems, dyspareunia, surgical interventions, injury, erosion, infection, bulging sensation in vagina, vaginal pressure, having to hold herself for bowel movement, rectocele, discharge and vaginal odor, bacterial vaginosis, constipation, mixed urinary incontinence, discomfort from the sling, dyspareunia, inability to reach orgasm, continued protective pad use, reported urethrolysis, removal of sling on cystoscopy, urethral reconstruction, anterior colporrhaphy on (b)(6) 2015, urinary tract infection, abdominal pain, tender suprapubic area, urinary frequency, pelvic pain, urgency, removal of mesh, infections, bladder leakage, colposcopies, chronic constipation, peritonitis and sepsis, recurrent vaginal pain, wound healing problems, clostridium difficile infection, uterine prolapse, disability due to mesh complications, depression, nonsurgical interventions and surgical intervention.

• Brand Name: Align® TO Trans-Obturator Urethral Support System - Hook & Halo
• Type of Device: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + 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: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8678812
• MDR Text Key: 147382048
• Report Number: 1018233-2019-02981
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00801741016233
• UDI-Public: (01)00801741016233
• 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: 06/07/2019

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 Model Number: BRD600HH
• Device Catalogue Number: BRD600HH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 61