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

Model Number 5196501022

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Incontinence (1928); Muscle Spasm(s) (1966); Pain (1994); Scarring (2061); Urinary Retention (2119); Urinary Frequency (2275); Discomfort (2330); Hematuria (2558); Dysuria (2684); Drug Resistant Bacterial Infection (4553); Fecal Incontinence (4571)

Event Type  Injury  

Manufacturer Narrative

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, the patient's legal representative stated pain, edema, nocturia, urgency, difficulty voiding, urinary incontinence, urinary retention, scarring, spasms, bleeding, incontinence, bladder spasms, vaginismus, dyspareunia, hematuria, and uti.

Manufacturer Narrative

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

Event Description

Additional information received further reported that the patient experienced the following: lower abdominal pain, suprapubic tenderness, nocturia every 30 minutes, blood in urine, urinary frequency/urgency, felt like bladder fell back down, lower urinary tract symptoms, felt something pop and urinary incontinence came back, cystocele noted on exam.Urinary hesitancy, suprapubic discomfort, continuous urinary dribbling, mixed urinary incontinence.Another manufacturer's device was implanted on (b)(6) 2014.Between (b)(6) 2014-(b)(6) 2016 the patient experienced pink/red colored urine, right lower abdominal pain, urinary leakage without awareness, incontinence, right inguinal pain, vaginismus, questionable vaginal abscess, urinary retention, urinary tract infection.New patient visit on (b)(6) 2015: states ob-gyn said her vaginal wall is coming through the bladder.Urinary incontinence 4-5x/day since altis implant, urinary incontinence primarily with valsalva, rare urinary incontinence with urge or while sleeping, occasional hematuria, states she feels and can see a vaginal bulge, fecal incontinence 2-3x/month primarily with cough/sneeze, significant dyspareunia, states urinary symptoms affect quality of life, states incontinence affects social life.On exam, thickening of anterior vaginal wall at the hymen, palpable unknown mid-anterior vaginal mesh, enlarged/long genital hiatus, mild recurrent cystocele, remote tailbone injury concerning for possible neurogenic component as it is unusual for a young woman to have this severe pop and enlarged/long hiatus.Thickening of the anterior vaginal wall that is at the hymen.Mid-anterior mesh, tenderness along anterior vaginal wall, questionable raised scar on right side of vagina.On (b)(6) 2015: intraoperative findings: no sign of mesh erosion or foreign body, tight/thick scar tissue from prior surgery noted on right side of urethrovesical junction, recurrent grade 3 cystocele (not related to altis), fine bladder trabeculations.Suprapubic pain is likely secondary referred pain from back disc/back problem.Mixed incontinence.(b)(6) 2015: excision/fulguration of vaginal scar tissue, cystocele repair with native tissue and prolene sutures, cystoscopy.Intraoperative findings: tight vaginal scar tissue in area of urethrovesical junction (1.5 cm) was like two hard rings that you could insert your finger excised/ fulgurated), additional tight scar tissue in anterior vagina from prior surgeries that was like a big ball (no dissection done/remains intact), vaginal canal appears straighter at conclusion of procedure.Suprapubic nodule, infective cystitis, vaginal abscess.It was further reported that the patient experienced dysuria and a urinary tract infection, which was positive for a multi drug resistant strain of methicillin-resistant staphylococcus aureus (mrsa).Intraoperative findings revealed no vaginal abscess.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 5996584
• MDR Text Key: 56374395
• Report Number: 2125050-2016-00268
• 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: Attorney
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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: Physician
• Device Model Number: 5196501022
• Device Catalogue Number: 5196501022
• Device Lot Number: 3560145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2016
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female