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

Model Number 5196502400

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

Patient Problems Itching Sensation (1943); Muscle Weakness (1967); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Anxiety (2328); Depression (2361); Intermenstrual Bleeding (2665); Dysuria (2684); Unspecified Gastrointestinal Problem (4491); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Sexual Dysfunction (4510); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 dyspareunia, impairment of sexual function, impairment of bowel and bladder function, recurrent urinary tract infections, disability, impairment of mobility, depression, anxiety, pain in pelvis, groin, thigh, rectum, and vagina.

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 10/29/2022 as follows: patient is experiencing urinary retention, dysuria, a mild weakness of the right lower extremity, vaginal spotting and itching.

• 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: 15246188
• MDR Text Key: 298107167
• Report Number: 2125050-2022-00797
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2022
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6596854
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2022
• Date Device Manufactured: 03/19/2019
• 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 Age: 40 YR