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

Model Number 5196502400

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

Patient Problems Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Urinary Retention (2119); Urinary Tract Infection (2120); Dysuria (2684)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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.(b)(4).

Event Description

As reported to coloplast, though not verified, the patient experienced complications associated with transvaginal mesh, including inter alia, urinary issues, severe pain with daily activities and intercourse, neuralgia and neuropathic pain, increased risk for injuries, infections and pain.The patient had undergone multiple corrective surgeries, and extensive medical treatment operations to locate and remove mesh, repair pelvic organs, tissue, and nerve damage, and received injections into various areas of the pelvis, spine, and the vagina.Operations took place to remove portions of the female genitalia.The patient also experienced scaring, urinary incontinence, physical deformity, and the loss of the ability to perform sexually.The sling was revised on (b)(6) 2017 and was explanted approximately two months later.

Manufacturer Narrative

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

Event Description

Additional information received on 11/02/2022 as follows: between 9/21/2017 and 12/29/2017 the patient experienced the following: urinary retention, left groin pain, urinary tract infection, dysuria, with the sensation of not emptying well, and urinary retention.Revision and release of the altis sling under general anesthesia.Significant issues with pain, neuropathic pain, headache, and voiding issues, burning pain in the vagina and in the legs bilaterally.Cystoscopy, suprapubic tube placement, transvaginal mesh removal, washout, urethrolysis, rectus fascia harvest, autologous rectus fascia harvest, pubovaginal sling, cystourethropexy under general anesthesia.Small dehiscence in the suprapubic incision 4 cm area just left of midline.

• 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: 10896117
• MDR Text Key: 218010859
• Report Number: 2125050-2020-01142
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

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: Lay User/Patient
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5200342
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 11/17/2022
• 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): Required Intervention
• Patient Sex: Female