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

Model Number	BRD400HK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Incontinence (1928); Pain (1994); Disability (2371)
Type of Reportable Event	Serious Injury
Additional 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, 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 over-correction/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 by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability and impairment.Per additional information received, the patient has experienced vaginal pain, groin pain, pain with intercourse/impaired sexual relations, urinary incontinence, fecal incontinence, heavy bleeding, chronic yeast infections, bladder infections, low back pain, emotional changes, pressure, cramping, pelvic discomfort, voiding blood tinged urine (hematuria), pain, and required nonsurgical interventions, dyspareunia, dryness, urinary incontinence, fatigue/insomnia, burning around vaginal area, vaginal discharge, atrophic vaginal mucosa, dysmenorrhea, dyspareunia, dysfunctional uterine bleeding, dysuria, endometrial biopsies, fecal incontinence, mixed stress and urge incontinence, dilation and curettage with hysteroscopy and insertion of mineral intrauterine device, endometrial cancer, total laparoscopic hysterectomy and bilateral salpingo-oophorectomy for treatment of endometrial cancer, post-coital bleeding, granulation tissue of vaginal cuff treated with silver nitrate, decreased ability to orgasm, groin pain made worse by walking, prolonged sitting, prolonged car ride, radiating to the back/ buttock at times, situational depression partly due to her dyspareunia and pain issues, vaginal bulge, frequency, urgency, vaginal bleeding, tender vaginal sling-band, rectocele, levator spasm, posterior vaginal wall prolapse, obstructive defecation symptoms, transobturator tape revision, right inguinal groin dissection, posterior repair with native tissue, trigger point injections of more than 3 muscle groups, severe urinary incontinence, anal pain, urge urinary incontinence, overactive bladder, stress incontinence, pelvic floor trigger point injections, coccygeal pain, urinary tract infection, lower back pain, and buttock pain.

• Brand Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK
• Common Device Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9750245
• Report Number: 1018233-2020-01304
• Device Sequence Number: 2871723
• Product Code: OTN
• UDI-Device Identifier: 00801741016219
• UDI-Public: (01)00801741016219
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: 10/31/2012
• Device Model Number: BRD400HK
• Device Catalogue Number: BRD400HK
• Device Lot Number: HUUJ1349
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/25/2020
• 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: 47 YR
• Patient Weight: 73