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

Model Number	BRD300RS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Erosion (1750); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: 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 or Problem Description
It was reported in the patient's medical records that as a result of having the product implanted, the patient has experienced the patient has experienced erosion, dyspareunia, pain, inability to empty bladder/control urination, urgency, pressure sensation, nocturia, high blood pressure, back pain, urine retention, numbness/tingling, too hot/cold, tiredness, sluggishness, indigestion/heartburn, rectocele (prolapse), tenderness, foreign body in patient, stress urinary incontinence, mesh exposure, blood loss, blood/bacteria/crystals/mucous in urine, inflammation, cramps, pelvic pain, abdominal pain, non-surgical and additional surgical interventions.Per additional information, the patient has experienced vaginal and anal spasms, husband complaints of something scratching him during intercourse, an 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, acute cystitis, 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 ((b)(6) 2011).She also underwent an additional explant surgery on (b)(6) 2012 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 RS URETHRAL SUPPORT SYSTEM
• Common Device Name: ALIGN® RS URETHRAL SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10896389
• Report Number: 1018233-2020-06359
• Device Sequence Number: 19640420
• Product Code: OTN
• UDI-Device Identifier: 00801741016196
• UDI-Public: (01)00801741016196
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2010
• Device Model Number: BRD300RS
• Device Catalogue Number: BRD300RS
• Device Lot Number: HUSL0809
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 71