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

Model Number 5196502400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Fever (1858); Micturition Urgency (1871); Incontinence (1928); Itching Sensation (1943); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Complaint, Ill-Defined (2331); Prolapse (2475); Patient Problem/Medical Problem (2688); Constipation (3274); Unspecified Kidney or Urinary Problem (4503); Urinary Incontinence (4572); Swelling/ Edema (4577)

Event Date 06/26/2015

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, the patient's legal representative stated recurrent incontinence, urgency, pain, lower abdominal pain with swelling, urinary incontinence, chronic pelvic pain, uti, severe sui.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, additional information received states: 6/26/2015 - 7/1/2015 excision of vaginal mesh, concern for early pyelonephritis, pseudomanas aeruginosa, significant inflammation and necrotic center of the surface of the bladder.3/6/2017 - 3/8/2017 urinary tract infection (uti) 4/11/2017 chronic constipation 5/5/2017 excision of mesh.9/11/2016 - 9/7/2017 er visits, patient experienced urinary tract infections (uti) vulvovaginal candidiasis, abdominal pain, fever, urinary frequency/dysuria, vaginal itching, monilla vaginitis.Admitted for acute pyelonephritis from (b)(6) 2017.Other symptoms were stress urinary incontinence, uterovaginal prolapse, cystocele, hematuria, abdominal pelvic pain, urinary leakage, burning and frequency, suprapubic tenderness, air in bladder, vaginal discharge.6/1/2020 - er with urge incontinence and bladder pain.7/6/2020 - 2/8/2021 uti, enterococcus, urgent incontinence, pain on right flank.Cloudy and malodorous urine, yeast infection, worsening urinary frequency and bladder spasms.

Manufacturer Narrative

Clinical sign and symptoms: e1311 kidney stone.

Event Description

Additional information received on 9/30/2022 as follows: on (b)(6) 2022 increased bladder pressure, leakage, frequent uti's and increased urgency, mild hydronephrosis and 7mm non-obstructing stone.Ua positive for uti with urine culture >100,000 cfu/ml.Escherichia coli esbl.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 6079151
• MDR Text Key: 59171563
• Report Number: 2125050-2016-00346
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5196502400
• Device Catalogue Number: 5196502400
• Device Lot Number: 3616231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female