MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR KIT; SURGICAL MESH

Model Number 5195512400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Cyst(s) (1800); Fever (1858); Fistula (1862); Micturition Urgency (1871); Prolapse (2475); Dysuria (2684); Dyspareunia (4505); Genital Bleeding (4507)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced sui, dyspareunia, uti¿s, grade 1 cystocele, grade 1 uterine prolapse, and a grade 1 rectocele, recurrent vaginal yeast infection, align midurethral sling placement, and cystoscopy for recurrent sui, post-op acute blood loss, anemia, dysuria, nausea, urinary urgency, hematuria, vaginal bleeding, abdominal pain, lower back pain, fever, urinary frequency, rlq pain with exquisite tenderness on palpation, vulvar pain and swelling, pain left vaginal area, vaginal spotting for 6-8 months, large cyst palpated on left vaginal sidewall extending to introitus to about 6 cm into the vagina, small abscess along left anterolateral vaginal wall ¿ measures 1.5 x 0.9 cm, incomplete emptying, cystocele, hematuria, inflammatory process- skin thickening in vaginal region, microhematuria, persistent bleeding of left labial cyst with induration and ulceration, urinary incontinence, cystocele, poor healing i&d site of left labia with polyps around the incision site, chronic skin changes, erythema, vulvar lesion with granulation tissue, minimal anterior prolapse, slight urethral mobility, vaginal swelling, brownish-thin discharge coming from the area, difficult for the patient to sit without pain, purulent vaginal drainage, an area of induration is palpable from inside the vaginal canal, abscess with granulation tissue- left labia, severe acute and chronic inflammation with granulation tissue, fistulous tract originating from the upper anterior vagina and extending along the left lateral aspect of the vagina extending to the skin surface of the left labia, double voiding, painful lesion in the left vulva/labia area with granulation tissue and discharge, painful passing of clots from the vulvar area, mesh exposure, new abscess formation in left labial area, abrupt rupture of vaginal cyst, fever, left labial fistula with increased pain and drainage, low grade fever, body aches, recurrent urinary incontinence, exposed suburethral mesh with fistulous tract with 2 openings on to the left labia majora, mildly elevated white blood cell count with small left shift, chronically infected and inflamed aris tot, mid-urethral mesh exposure, non-healing left labial defect with granulation tissue, left mesh exposure with left groin sinus tract communicating with left labia majora, pain over labial incision that worsens with sitting, purulent discharge from incision site with redness, warmth and swelling, increased vulvar discomfort.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12298929
• MDR Text Key: 265779467
• Report Number: 2125050-2021-01126
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2021

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: Lay User/Patient
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2021
• Initial Date FDA Received: 08/10/2021
• 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 Age: 49 YR