MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURGICAL MESH

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Erosion (1750); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Myalgia (2238); Injury (2348); Hematuria (2558); Dysuria (2684); No Information (3190); Dyspareunia (4505); Decreased Appetite (4569); 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, patient's legal representative stated, plaintiff experienced significant mental and physical pain and suffering, has sustained permanent injury including pudendal neuralgia, obturator neuralgia, pelvic floor tension myalgia, hip adductor myalgia, complex regional pain syndrome, erosion, recurrent urinary tract infections, interstitial cystitis, chronic dyspareunia, bowel and bladder dysfunction, and anorectal pain, and has undergone medical treatments, surgical procedures related to failure of the device.

Event Description

Additional information received indicates that on (b)(6) 2021 the patient was experiencing nausea and a loss of appetite.

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

Additional information received on (b)(6) 2020 reported the patient experienced severe groin pain, urine and bowel problems, acute cystitis with hematuria and uti.Additional information received on (b)(6) 2020 reported that the patient experienced a possible ti as of (b)(6) 2017; continued severe groin/pelvic pain as of (b)(6) 2017; partial removal of sling as of (b)(6) 2017; bladder and bowel incontinence and painful intercourse as of (b)(6) 2018; and a complete mesh removal as of (b)(6) 2019.Additional information received on (b)(6) 2021 reported that the patient experienced severe left hip / groin pain; possible nerve impingement from sling; very tender pelvic floor; groin pain that radiates to rectum; gait changes since sling was placed; nocturia 4x per night; vestibulitis and vulvodynia; severe hyperaesthesia of entire vagina; distal scar tissue or persistent band of vaginal mesh from sling on right side was palpated; high tone pelvic floor dysfunction; oab syndrome; urinalysis with yeast, and significant emotional distress.Bilateral leg weakness and pain, incomplete defecation, back pain.Uds findings show no obstruction with data but clinically voiding patterns and difficulty emptying are consistent with obstruction, which could be secondary to scar tissue from sling or sling itself.Obturator and pudendal neuralgia, bilateral groin pain, bladder spasms, painful bowel movements, dyspareunia with consortium complaints of feeling mesh, pain with sitting from the rectum to the vagina.Additional information received further reported that the patient underwent a pudendal nerve block under moderate sedation and it was further reported that the patient also experienced dysuria.A urine culture was positive for proteus.Mirabilis.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 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: 9351330
• MDR Text Key: 167336682
• Report Number: 2125050-2019-01047
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2022

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: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 3432363
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 10/25/2019; 10/14/2022
• Supplement Dates FDA Received: 10/11/2022; 10/19/2022
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female