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

Model Number 5196502400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Fever (1858); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Myalgia (2238); Distress (2329); Prolapse (2475); Hematuria (2558); Nervous System Injury (2689); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

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

As reported to coloplast, though not verified, legal representative states the patient with this device experienced nerve injury and permanent damage, physical impairment, pain and suffering, loss of earnings and loss of earning capacity.

Event Description

Additional information received on 10/23/2022 indicates the following: between 4/28/2020 and 11/18/2021 the patient continues to feel pain and is experiencing myalgia and dyspareunia.Removal of the midureteral sling was performed along with excision of a skene's gland cyst.Patient is also experiencing muscle spasms, right leg weakness and continues to experience urge and stress urinary incontinence.

Manufacturer Narrative

Correction: medical device code.

Event Description

Additional info received on 11/07/2022 as follows: beginning 3/18/2020 through 3/30/2020 the patient was experiencing spotting from the bladder repair suture and right groin and blood discharge.Urine test revealed leukocytes.

Manufacturer Narrative

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

Event Description

Additional information received on (b)(6) 2023 indicates that beginning (b)(6) 2020 extending through (b)(6)2022 the patient experienced new symptoms as follows: burning sensation in right inguinal crease, fever, acute cystitis with hematuria.A malodorous vaginal discharge, urinary retention, and pain in the lower abdomen.No additional information was provided.

Event Description

Additional information received on 6/12/2023 states that in 2022 the patient underwent an additional surgery for attempted removal of the right sling anchor; however, it could not be located.Scarring was observed in the right groin.

Manufacturer Narrative

Additional review determined portions of this event were also reported under manufacturer report number 2125050-2022-00236.Complaint records have since been merged and any additional information received regarding this event will be reported under this manufacturer report number, 2125050-2022-01030.

Event Description

Additional information received on 9/29/2023 indicates that the patient is also experiencing worsening bladder prolapse and constipation.

• 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: 15550278
• MDR Text Key: 301248693
• Report Number: 2125050-2022-01030
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2023

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: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 10/23/2022; 11/07/2022; 02/19/2023; 06/12/2023; 08/02/2023; 09/29/2023
• Supplement Dates FDA Received: 10/29/2022; 11/18/2022; 02/24/2023; 06/13/2023; 08/02/2023; 10/05/2023
• 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