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

Catalog Number	BRD600HH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); 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: 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 one episode of vaginal bleeding, dyspareunia, stress urinary incontinence, decreased libido, biopsy of vaginal lesions, fibroepithelial polyp, swelling to bilateral lower extremities, tight and a sensation like a "guitar string" in vagina during intercourse, husband stated it felt like a cheese slicer and no longer having intercourse secondary to pain, urgency, urge incontinence, urinary frequency, nocturia, leg/groin pain, foreign body in vulva and vagina, chronic pain in right and left thigh, genital prolapse, hypermobile bladder neck, vaginal erosion from transvaginal tape, dysuria, vaginal pain, mesh exposure, urethral scarring, scar tissue and cystocele dissection, infected mesh, and urine leakage.She has required surgical and non-surgical interventions.

• Brand Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO
• Common Device Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9799990
• Report Number: 1018233-2020-01606
• Device Sequence Number: 610249
• Product Code: OTN
• UDI-Device Identifier: 00801741016233
• UDI-Public: (01)00801741016233
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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: 08/31/2012
• Device Catalogue Number: BRD600HH
• Device Lot Number: HUUG2120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 18 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/06/2020
• 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: 100