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

Model Number 5195512400

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Micturition Urgency (1871); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Chills (2191); Distress (2329); Hematuria (2558); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot number 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, legal representative stated the patient with this device experienced chills, nocturia, urinalysis with 1+ leukocyte esterase and 11-20 white blood cells, gross hematuria, recurrent urinary tract infections, cloudy urine, dysuria, pain, cystitis, hematuria, complaints of irritation post coitus, urinalysis red in color, urinary urgency with urge incontinence, intermittent pelvic pain, some progressive inability to urinate, urinary leaking, and strong urges to urinate with gushes of urine loss.Patient underwent a cystoscopy with intended laser of urethral stone under general anesthesia.A calcified area was noted on the right side of the urethra.Attempt was made to laser the calcification before it was identified as a portion of the eroded device which could not be easily removed.An attempt was made to cut the device which was not successful.Surgery was discontinued.On digital rectal exam, scarring was palpable with no extruded device that was palpable.Cystoscopy findings noted intraurethral device visible in the mid urethra extending from the 6-9 o¿clock positions resulting in distortion of the urethra and a bladder stone was noted.Diagnosis noted erosion of implanted urethral device into surrounding tissue, erosion of implanted device to surrounding organ or tissue, spasmodic bladder and urinary tract infection symptoms.Patient had urethroplasty, explantation of urethral device and cystoscopy under general anesthesia.Findings noted device exposure within the proximal third of the urethra from the 5 to 8 o'clock position.No erosion noted into the bladder and no involvement of the bladder neck.Device was explanted, approximately 2 to 3 cm laterally on each side of the urethra.A 1 x 2 cm urethral defect visualized and closed in two layers including the mucosa as well as the periurethral muscle and fascia.Pathology received in buffered formalin two pieces of device with adherent tissue measuring 3.5 x 0.3 x 0.2 cm and 2.6 x 0.4 x 0.3 cm.

Event Description

Additional information received on 6/30/2023 states the patient subsequently suffered complications associated with the pelvic mesh product, dyspareunia, urinary incontinence, and difficulty with daily activities.Patient has also suffered severe emotional pain and injury.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16180170
• MDR Text Key: 307457165
• Report Number: 2125050-2022-01494
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• 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,Followup
• Report Date: 07/06/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 3518027
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/06/2023
• Date Device Manufactured: 11/26/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 74 YR