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

Model Number 5196502400

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Fungal Infection (2419); Foreign Body In Patient (2687); Constipation (3274); Genital Bleeding (4507); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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, this partially removed due to erosion and the sling was tight.Subsequently, after the partial explant, the patient began to experience groin and leg pain that was consistent of nerve damage.It was reported that the pain is ongoing and requires ongoing medical care.

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 urinary frequency, urgency, dysuria, recurrent urinary tract infections, urinary burning and pressure, pelvic floor and perineum area spasms, abdominal cramping, burning and pain during intercourse, spousal discomfort during intercourse, difficulty emptying bladder, exposure of mid urethral sling at midline, yeast infection, rectal prolapse, bright red bleeding, bleeding after intercourse, vaginal scarring, posterior vaginal wall discomfort, mild tenderness in the bilateral obturator internus, tailbone pain, can feel mesh, stress urinary incontinence, vaginitis, pressure in the vagina, hemorrhoids, constipation, anal pain with wiping, pain with bowel movement lasting up to 24 hours and wakes her up from sleep and visible midline suture at 10 weeks.Patient had excision of exposed vaginal mesh and cystoscopy with general anesthesia.Pathology showed foreign material from vaginal mesh.It was also noted that a 3 mm area of exposed mesh consisted with mid urethral sling in left periurethral region and 1 mm region of mesh fibers in right periurethral region.It was also noted, that the patient had exposed mesh explanted in doctor's office without anesthesia.Patient had physical and occupational therapy and also experienced loss of function with physical activity, running, yard work, self care and intercourse and pain on a scale of 8/10.Pain was noted on the left side of the following areas rectum, labia, clitorial hood, pubic area, urethra and anal pain particularly after intercourse.

Event Description

Additional information received reported that the patient's urinary tract infections had been positive for klebsiella pneumoniae and escherichia coli.

• 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: usjki jennifer kinneman ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11796939
• MDR Text Key: 249697035
• Report Number: 2125050-2021-00482
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2022

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 Expiration Date: 07/14/2019
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5088007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 04/12/2021; 03/10/2022
• Supplement Dates FDA Received: 02/21/2022; 03/29/2022
• Date Device Manufactured: 07/14/2016
• 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: 57 YR
• Patient Sex: Female