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

Model Number 5196502400

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abscess (1690); Erosion (1750); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Frequency (2275); Constipation (3274); Dyspareunia (4505); Genital Bleeding (4507); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced pelvic pain, dyspareunia, bladder pain, levator ani muscles taut and tender to palpation, episodic bleeding during intercourse, a constant feeling of a full bladder, weak stream, mixed urinary incontinence, overactive bladder, urinary incontinence, wears 1 or 2 pads daily, nocturia 2 to 3 times per night, and urinary retention.Patient went to the emergency room for constipation, a ct scan showed 1.6 cm collection at the cuff and possible abscess.She had an emergency department visit for pain.Patient had a pelvic exam and was tender vaginally, mostly along levator ani muscles.Another physical exam revealed granulation tissue at left vaginal apex about 3 mm, pain from intercourse was reproduced with tenderness to posterior wall palpation.Patient had a pelvic exam showed exposed device in the anterior vaginal directly below the urethra in the midline.Patient had a partial explantation of the device under general anesthesia.Intraoperative findings noted a very small proximally 2 mm area of exposed device and dense scar tissue noted around the device.Patient had a small loose suture removed, urination improved and is still having post op pain.

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.

• 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: 16091103
• MDR Text Key: 306566744
• Report Number: 2125050-2022-01458
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2019
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 4921161
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2022
• Date Device Manufactured: 02/26/2016
• 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: 48 YR