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

Model Number BRD500HL

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

Patient Problems Muscle Spasm(s) (1966); Urinary Tract Infection (2120); 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® 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

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received, the patient has experienced incomplete bladder emptying requiring intermittent self-catheterization, muscle spasms, acute cystitis, vaginitis, vulvovaginitis, recurrent urinary tract infections, mild urinary incontinence, complete exposure of vaginal sling mesh requiring in office mesh removal, mixed urge and stress incontinence requiring an unknown type of suprapubic sling placement and cystourethroscopy, followed by vaginal and anal spasms, husband complained of something scratching him during intercourse, requiring another in office excision of anterior vaginal mesh, recurrent urinary incontinence, dysuria, frequency, vaginal atrophy, continued pain with intercourse and several areas of mesh fiber that were visible and required surgical excision, partial vaginectomy, cystourethroscopy, vaginal scarring.Per additional information received, the patient has experienced incomplete bladder emptying requiring intermittent self-catheterization, muscle spasms, acute cystitis, vaginitis, vulvovaginitis, recurrent urinary tract infections, mild urinary incontinence, complete exposure of vaginal sling mesh requiring in office mesh removal and application of silver nitrate, mixed urge and stress incontinence requiring an unknown type of suprapubic sling placement and cystourethroscopy, followed by vaginal and anal spasms, husband complained of something scratching him during intercourse, requiring another in office excision of anterior vaginal mesh, recurrent urinary incontinence, hematuria, chronic pain disorder, pelvic organ prolapse, constipation, a small anterior vaginal wall ulceration, enterocele, rectocele, dysuria, frequency, vaginal atrophy, continued pain with intercourse and several areas of mesh fiber that were visible and required surgical excision, partial vaginectomy, and cystourethroscopy (12/1/11).She also underwent an additional explant surgery on 11/28/12 due to dyspareunia, chronic pain, foreign body in vagina, and an eroded urethral sling.There was a palpable ridge where the previous urethral sling had been, but this was not exposed and the decision was made not to remove this ridge.The pathology report confirmed mesh (gross examination only).After this she had a small anterior vaginal wall ulceration that appeared to have been epithelialized, enterocele, and rectocele.Per the pfs, she also experienced bowel perforation and irritable bowel syndrome.It¿s unclear whether these complications are attributed to the (b)(6) 2008 or (b)(6) 2009 implant surgeries.Per additional information received, the patient alleged that she has experienced mesh erosion, emotional trauma, dyspareunia, vaginal pain, loss of consortium, frequency, inability to empty bladder, feeling pieces on mesh in her vagina, multiple mesh removals, bowel perforation, chronic constipation, irritable bowel syndrome, cystocele, rectocele, recurrent or chronic vaginal or bladder infections, urinary incontinence, urinary retention, uterine prolapse, and vaginal vault prolapse.She allegedly required multiple non-surgical and surgical interventions.Per additional information received, the patient continued to have pain due pieces of implant eroding into vagina, and had impaired sexual relations, physical injuries, emotional trauma, crohn's disease, irritable bowel syndrome, ulcerative colitis, or chronic diarrhea, dyspareunia, recurrent or chronic vaginal or bladder infections, recurrent vaginal pain, urinary incontinence, urinary retention, uterine prolapse, vaginal vault prolapse, depression, hematuria, urinary frequency, coastal spine & pain, mid back pain, low back pain at multiple sites (6/10), lumbar postlaminectomy syndrome, chronic pain syndrome, spasm of back muscles, additionally the patient underwent additional surgical and non-surgical interventions.

• Brand Name: ALIGN TO URETHRAL SUPPORT SYSTEM - HALO
• Type of Device: ALIGN® TO URETHRAL SUPPORT SYSTEM - 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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10896141
• MDR Text Key: 218245421
• Report Number: 1018233-2020-06358
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00801741016226
• UDI-Public: (01)00801741016226
• 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: 11/24/2020

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: 10/31/2009
• Device Model Number: BRD500HL
• Device Catalogue Number: BRD500HL
• Device Lot Number: HUSI2262
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• 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: 40 YR
• Patient Weight: 73