MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Pain (1994); Injury (2348)

Event Date 11/26/2018

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, patient's legal representative stated patient suffered significant injury and harm.

Manufacturer Narrative

D1: brand name corrected from unknown fem pelvic health mesh to altis single incision sling system.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received further reported that the patient experienced residual pain from the defective mesh, chronic pain, bleeding, discharge, wound separation, mesh exposure, erosion, stress incontinence, inflammation, dyspareunia, dysuria, hematuria, urinary frequency, lethargy, suture in the vagina, palpable mesh exposure along the right sulci, pelvic organ prolapse, mild vaginal atrophy, pelvic pressure, an open vaginal wound (1.5 cm), vaginal wound closure and cystoscopy under general anesthesia, and an open midline wound with mesh exposure.The mesh was removed.The patient was prescribed bactrim ds and premarin cream.A surgical closure was planned.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 9182020
• MDR Text Key: 162045479
• Report Number: 2125050-2019-00861
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6285089
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 09/06/2022
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female