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 Pain (1994); Unspecified Kidney or Urinary Problem (4503)

Event Date 04/26/2022

Event Type  Injury  

Manufacturer Narrative

Citation: melon j, karjalainen pk, mcgannon c, lee jk, rosamilia a.Medium-term clinical efficacy and safety of single incision and modified trans-obturator mid-urethral slings for female stress urinary incontinence.Gocm 2 (2022) 57-62.Https://doi.Org/10.1016/j.Gocm.2022.04.004.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.

Event Description

According to the available information, of the 60 women implanted with altis between 2012 and 2018 who were available for final analysis related to this study: -two slings were removed or "divided"; one was "divided" five months post op for chronic low-grade voiding dysfunction following episodic clean intermittent self-catheterization.-one sling was loosened early for voiding dysfunction.-two patients received repeated slings; one sling had been removed a week post op for severe groin pain.A retropubic sling was placed at that time.-early groin or vaginal pain lasting up to three months was reported as higher in the altis group.In the single-incision-sling group, all pain was reported as resolved before three months, except for three altis patients who reported resolution at 3, 6, and 12 months respectively, with simple analgesia and physiotherapy.

• 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: 16018426
• MDR Text Key: 305870555
• Report Number: 2125050-2022-01418
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2022

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: Lay User/Patient
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/20/2022
• 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: 55 YR
• Patient Sex: Female