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

Model Number 5196502400

Device Problem Material Erosion (1214)

Patient Problems Abdominal Pain (1685); Erosion (1750); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Fungal Infection (2419); Hematuria (2558); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572)

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, legal representative stated the patient with this device experienced dyspareunia, pelvic pain, urinary problems, erosion, exposure, recurrence of incontinence, rectal pain, infections, and abdominal pain.The device was explanted.The patient is receiving ongoing medical treatment for her injuries.

Event Description

Additional info received on 11/3/2022 as follows: between (b)(6)2018 and (b)(6)2022 the patient experienced the following: dysuria, yeast infection with a negative urine culture, hematuria, urinary tract infection with e coli and vaginal discharge.

Manufacturer Narrative

Correction: item number, lot number, udi number.The corrected lot number was reviewed for complaint trend, nonconforming report and capa.¿ devices met specification prior to release and no trends were noted.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.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15610804
• MDR Text Key: 301809700
• Report Number: 2125050-2022-01081
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2022
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5645153
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2022
• Date Device Manufactured: 10/23/2019
• 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 Sex: Female