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

Model Number 5196502400

Device Problem Migration (4003)

Patient Problems Wound Dehiscence (1154); Erosion (1750); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Depression (2361); Prolapse (2475); 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 nausea associated with post-op pain medication, difficulty controlling pain due to heightened pain sensitivity and past history of narcotic use, separation of left superficial mucosal stitch, soreness, pain, discomfort with sitting, felt nodules in vagina, slow healing from implant surgery, tightness in left thigh at the junction to mons pubis, dyspareunia, bilateral groin pain, perineal pain, feeling depressed and miserable given her symptoms, pelvic pain, urinary incontinence, uterovaginal prolapse, urinary tract infection, pain with certain posture movements, vaginal scar fibrosis, rectal pain, and vulvovaginitis.Examination noted palpable device erosion just below the urethra distal to the ureterovesical junction, vaginal mucosa was dry and atrophied, uterine prolapse, and stage 1 cervical prolapse.

• 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: 15754301
• MDR Text Key: 303258656
• Report Number: 2125050-2022-01215
• 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
• Report Date: 11/08/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2022
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6853312
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 11/08/2022
• Date Device Manufactured: 08/19/2019
• 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: 55 YR
• Patient Sex: Male