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

Model Number 5196502400

Device Problems Material Erosion (1214); Unstable (1667)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Obstruction/Occlusion (2422)

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.Once our evaluation is complete, 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

According to the available information, though not verified, recurrent sui, urgency with detrusor instability, uti, altis sling scarred up to the urethra but not eroded or obstructing.Uti with klebsiella pneumoniae.On (b)(6) 2019 - laparoscopic excision of y mesh, laparoscopic trachelectomy, laparoscopic partial vaginectomy, laparoscopic suture colpopexy, laparoscopic burch procedure, cystourethroscopy, and laparoscopic enterolysis.On (b)(6) 2020 - vaginal pain, atrophic vaginitis.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

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 on (b)(6) 2021 the patient was experiencing or had experienced incomplete emptying, slow flow, recurrent urinary tract infections, palpable partial obstruction of mid urethra from sling (bladder outlet obstruction), and scarring from sling with roping.On (b)(6) 2021 the patient was experiencing or had experienced sling mesh and fibrous tissue with chronic inflammation and foreign body giant cell reaction.

• 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: 10988917
• MDR Text Key: 220884725
• Report Number: 2125050-2020-01252
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

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: 5076609
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female