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 Pulmonary Embolism (1498); Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Sepsis (2067); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Depression (2361); Hematuria (2558); Dysuria (2684); Thrombosis/Thrombus (4440); Unspecified Respiratory Problem (4464); Eye Infections (4466); Kidney Infection (4502); Decreased Appetite (4569); Swelling/ Edema (4577)

Event Date 04/19/2016

Event Type  Injury  

Event Description

According to available information, this device required medication due to recurrent urinary tract infections.The patient experienced recurrent urinary infections, hemorrhagic urine, vaginal pain, urethral pain, blockage of the right leg at the level of the groin, invalidating pain in the lower part of the sacrum and the right lower limb, wears support stockings every day, multiple thrombosis right leg complicated, right pyelonephritis, severe septicemia, lower back pain, and anorexia.The patient has been on antibiotics all year but infections came back, she is taking sleeping pills, taking painkillers, has permanent pain, burning, excessive urination with more than 30 per day, gets up at night a minimum of 10 times, is handicapped and doesn't go out anymore, isolated with no social activity, and has depression.Patient was hospitalized and had a thoracic angioscan and abdominal-pelvic ct for a bilateral pulmonary embolism predominantly on the right side.She was confined to bed after an emergency embolization of renal angiomyolipoma.She had shortness of breath, edema in left leg and thigh, asthenia following multiple left eye surgeries with corneal infection.Patient had an ultrasound for deep vein thrombosis.

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.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.

Manufacturer Narrative

B1: corrected to "adverse event" only h6 health effect codes: corrected add e1301 dysuria and e1616 loss of range of motion.Correction includes removal of the following codes, as additional review determined they were not applicable: e0306 sepsis, e0514 thrombosis/thrombus, e131001 kidney infection, e0752 unspecified urinary problem, e050303 pulmonary embolism, e2306 decreased appetite, e0818 eye infection, e1621 muscle weakness/atrophy, e2338 swelling/edema, and e020202 depression.

• 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: 16099461
• MDR Text Key: 306677065
• Report Number: 2125050-2022-01462
• 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: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

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 Operator: Lay User/Patient
• Device Model Number: 5196501022
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/07/2023
• 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 Sex: Female