MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number 519650

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Itching Sensation (1943); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Abdominal Cramps (2543); Dysuria (2684); Genital Bleeding (4507)

Event Date 09/02/2021

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced recurrent erosion and device exposure along the anterior vaginal wall.The patient had an exam, hysteroscopy with endometrial sling sampling, and focal excision of midurethral device under general anesthesia.The patient had an exam, robotic assisted laparoscopic hysterectomy, bilateral salpingectomy, cystoscopy and revision of midurethral device under general anesthesia.

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.

Manufacturer Narrative

This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.

Event Description

Additional information received on (b)(6) 2023 indicates that the patient is experiencing recurrent urinary tract infections, urinary frequency and urgency, pain, vaginal bleeding, dysuria, itchiness, incontinence, and abdominal cramping.

Manufacturer Narrative

Portions of this event were previously reported under mfg report number 2125050-2023-01214 & 2125050-2023-01031 & 2125050-2023-01028.Any additional information received regarding this event will be reported under this mfg report number 2125050-2023-00863.

• 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17388333
• MDR Text Key: 319739466
• Report Number: 2125050-2023-00863
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/25/2019
• Device Catalogue Number: 519650
• Device Lot Number: 4921161_5196502400
• Date Device Manufactured: 02/26/2016
• 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: 62 YR