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

Model Number 5196501022

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Discharge (2225); Infection, Indirect (2245); Hematuria (2558); Intermenstrual Bleeding (2665); Swelling/ Edema (4577)

Event Date 04/26/2016

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 uti, hematuria, incontinence, chronic cystitis with hematuria, left lower quadrant pain, vaginal pain, discharge, 2 cm mesh exposure at midline which appeared chronically infection, recurrent uti x 1 year, recurrent sui, and dyspareunia.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information received.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 uti, hematuria, incontinence, chronic cystitis with hematuria, left lower quadrant pain, vaginal pain, discharge, 2 cm mesh exposure at midline which appeared chronically infection, recurrent uti x 1 year, recurrent sui, and dyspareunia.Additional information received indicated patient's legal representative stated severe pain with daily activities and intercourse.

Event Description

As reported to coloplast, though not verified, additional information received states that between (b)(6) 2013- (b)(6) 2020: groin tenderness, pelvic pain, spontaneous loss of urine, vulvovaginitis, back pain, uti symptoms of frequency/hesitancy/incontinence, vaginal bleeding, increased urinary incontinence, nearly complete excision of exposed/extruded/infected altis sling ((b)(6) 2016).Intraoperative findings: 2 cm area of midline exposure with yellow discharge coming out around it, infected, completely loose/not adherent at all to tissue/completely detached from body, likely chronic infection is so bad the tissues are falling apart and the sling was just not holding anymore, sling eroded extensively into anterior vaginal wall, complete removal of left arm of sling with attached permanent suture, vast majority removal of right arm of sling (few millimeters remain deep behind pubic bone).Lower abdominal cramping, pelvic pain with intercourse, left sided flank pain, chronic cystitis (large l renal pelvic stone may be cause of hematuria and flank pain).

Manufacturer Narrative

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

• 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: 5991941
• MDR Text Key: 56099927
• Report Number: 2125050-2016-00248
• 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: 08/30/2022

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: Physician
• Device Model Number: 5196501022
• Device Catalogue Number: 5196501022
• Device Lot Number: 3616248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: 09/29/2016; 11/19/2020
• Supplement Dates FDA Received: 06/11/2018; 08/30/2022
• 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: 46 YR
• Patient Sex: Female