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

Model Number	BRD600HH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Tingling (2171); Numbness (2415)
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).Sample not received.
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, and disability.Per additional information received, the patient has experienced low back pain, urinary frequency, hesitancy, vaginal discharge, slow healing, occasional stress incontinence, urinary urgency, granulation tissue, constipation, acute onset of left leg pain, chronic urinary tract infections, drain in the cul-de-sac draining serosanguinous fluid, inflammation, spotting, pelvic pain, cystitis, frank incontinence, light erythema over labia majora and minora about 1cm up onto the mons, foley catheter placement, infectious process coming from the pelvis and/or the bladder, subcutaneous fluid or edema in proximal left thigh medially and suprapubic area in the vulvar area, cellulitic rash on lower abdomen, groin and thighs, severe abdominal pain, left groin and vulvar cellulitis, bleeding, computed tomography guided drain in pelvis, leukocytosis, pain in left proximal thigh, vulva, pubic symphysis and left inguinal area, left proximal thigh cellulitis, pelvic fluid collection culture positive for group a streptococci, polymicrobial cellulitis, acute kidney injury, ileus, patchy erythematous areas on left groin, hyperbilirubinemia, thrombocytopenia, adult respiratory distress syndrome secondary to cellulitis/sepsis, computed tomography guided pelvic fluid aspiration four times, removal of transgluteal drain, abdominopelvic abscesses and pain, terminal dysuria, pelvic cellulitis and myositis, presacral and left and right obturator abdominal pelvic abscesses, abdominopelvic abscess with moderate growth b-hemolytic streptococcus epidermis, pyomyositis, reactive retroperitoneal and bilateral lymphadenopathy, abscess on left obturator internus/externus, presacral and right obturator internus, possible subclinical infection from her sling or somehow the area was disrupted in her fall, left lower quadrant and left hip pain, osteomyelitis, mild dilatation of the mid right ureter, long term use of high-risk medication and opiates, anxiety, persistent pockets of infection, chronic pelvic pain, buttock pain, vaginal bleeding, pelvic abscesses, left leg numbness-occasionally gives out, bilateral groin pain, unable to empty bladder completely, pain with sex, cystocele, yeast vaginitis, pelvic tenderness, questionable rectal abscess, urinary leakage, diarrhea and bloody stool, pelvic myositis, small residual presacral abscess, bilateral ovarian cysts (likely follicular), vaginal pain, hip pain, abdominal wound dehiscence with granulation tissue after sling removal, numbness and tingling in lower extremities (thigh, lower leg and buttock regions), stool incontinence, and pelvic abscess drain.She has required multiple 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: 9750453
• Report Number: 1018233-2020-01305
• Device Sequence Number: 2872349
• 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: 2015
• 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: 10/31/2016
• Device Model Number: BRD600HH
• Device Catalogue Number: BRD600HH
• Device Lot Number: HUYJ1183
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 12 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: 41 YR
• Patient Weight: 108