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

Model Number 5196502400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Laceration(s) (1946); Pain (1994); Skin Erosion (2075); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Discomfort (2330); Hematuria (2558); Dysuria (2684); Fibrosis (3167); Dyspareunia (4505); Genital Bleeding (4507); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, legal representative stated (b)(6) 2018 excision surgery for erosion in the midportion of the sling requiring a partial removal.(b)(6) 2019 second excision surgery for erosion on the right side of the vaginal wall.Seen in the er and subsequently admitted to the hospital in (b)(6) 2019 with complaints of pelvic and hip pain, malodorous vaginal discharge and dyspareunia.Evaluated in the er (b)(6) 2019 for complaints of pelvic pain, stress incontinence and dyspareunia.No other adverse patient effects were reported.

Event Description

Additional information received further reported that between (b)(6) 2018 and (b)(6) 2020, the patient experienced the following: blood in the vaginal area, urethrocele repair, and removal of a vaginal nodule.Sling erosion was noted to be approximately 05-1.0 centimeters, hematuria, a wet mount positive for clue cells, ovarian cysts/follicles, pulling sensation in the abdominal cavity, dysuria, bacterial vaginosis, protruding bladder sling, difficulty voiding, mesh in the vaginal area, discomfort for her partner, limited feeling in the vagina due to multiple surgeries, pelvic floor tenderness, pink vaginal discharge, chest pain, difficulty voiding, urgency, chronic infections, a small superficial laceration, urinary tract infection, burning with urination, cystitis, patchy submucosal fibrosis, and chronic inflammation.A retroperitoneal ultrasound had normal results.

• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12530726
• MDR Text Key: 273319794
• Report Number: 2125050-2021-01373
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/15/2021
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6030013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female