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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
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COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER Back to Search Results
Model Number 5196501022
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Hematuria (2558); Dysuria (2684); Neuralgia (4413); Unspecified Kidney or Urinary Problem (4503); Skin Inflammation/ Irritation (4545); Fecal Incontinence (4571)
Event Type  Injury  
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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 pain and urinary issues after partial explantation of the device.The patient also had a neurectomy due to persistent nerve pain and another procedure to explant the device.
 
Event Description
Additional information received on 10/26/2022 as follows: 09/09/2016 posterior repair with mesh augmentation utilizing acell graft and perineorrhaphy ¿ general anesthesia.(b)(6) 2021, operative report ¿ robotic upper vaginectomy with partial excision of eroded unknown mesh, robotic burch procedure, sacral colpopexy with artisyn mesh, bilateral salpingectomy ¿ general anesthesia intraoperative findings: patient had about a 2 cm eroded area the mesh at the apex of the vagina pathology report: upper vagina with oldest mesh consists of one tan, unoriented tissue fragment measuring 3.0 x 2.5 x 1.0 cm.The cut surface shows synthetic material.The synthetic material is for gross only.(b)(6) 2022, exploratory laparotomy with removal of portion of the (artisyn & unknown mesh) sacropexy mesh, transvaginal sacropexy mesh excision with transvaginal altis sling removal, right-sided ilioinguinal neurectomy, removal of burch sutures ¿ general anesthesia intraoperative findings: sacropexy mesh which had eroded into the vagina was excised both transvaginally and via laparotomy.Tvt-o mesh was removed including the anchor on the right side.Pathology report confirms mesh.Sacropexy mesh - 4.9 x 1.2 x 0.6 cm.Ulcerated skin which acute inflammation, foreign body giant cell inflammation, and foreign body consistent with mesh.Tvto mesh ¿ 5 x 2.0 x 0.6 cm.Fibrous tissue, with foreign body giant cell reaction and foreign body consistent with mesh.Skin with chronic inflammation.Ilioinguinal nerve ¿ 1.5 x 0.3 x 0.3 cm.Large nerve fibers with surround fibroadipose tissue.
 
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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
Additional information received on 1/31/2023 provides additional patient symptoms to include bowel incontinence.
 
Event Description
Additional information received on 3/14/2024 provides additional patient symptoms of yellow-green vaginal discharge and hematuria.
 
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Brand Name
ALTIS SINGLE INCISION SLING SYSTEM
Type of Device
FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
Manufacturer (Section D)
COLOPLAST A/S
1 holtedam humlebaek, dk 3050
humlebaek 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usbes brian schmidt
1601 west river road n
minneapolis, MN 55411
8007880293
MDR Report Key15152130
MDR Text Key297129903
Report Number2125050-2022-00750
Device Sequence Number1
Product Code PAH
UDI-Device Identifier05708932467407
UDI-Public05708932467407
Combination Product (y/n)N
PMA/PMN Number
K121562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 04/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5196501022
Device Catalogue Number519650
Was Device Available for Evaluation? No
Date Manufacturer Received10/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient SexFemale
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