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); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Erosion (1750); Pain (1994); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Dysuria (2684); Foreign Body In Patient (2687); 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, this patient had a foreign body reaction to this device.Additionally, she experienced pain, dyspareunia, difficulty voiding, difficulty emptying bladder, burning sensation, infections and other injuries.

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 the following dates the patient had experienced or was experiencing the following symptoms: on (b)(6) 2017: recurrent stress urinary incontinence (sui).On (b)(6) 2018: dysuria (dysuria was also in the patient¿s medical history prior to altis sling placement).On (b)(6) 2019: recurrent urinary tract infections (uti) and back pain (both symptoms were in the patient¿s medical history prior to altis sling placement).On (b)(6) 2019: 5-10 mm area of mesh erosion in the bladder near the left trigone, recurrent utis, urinary frequency, dysuria, low pelvic pain and mixed incontinence.The weave of mesh was not consistent with sling mesh.On (b)(6) 2019: mesh erosion into the bladder on the low posterior wall and recurrent sui.On (b)(6) 2019: recurrent utis, 2-3mm area of several vaginal mesh fibers eroded through the bladder mucosa.Surgical interventions were noted on (b)(6) 2017 and on (b)(6) 2019.In addition to altis, the patient also had an unknown mesh implanted on (b)(6) 2017.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11841129
• MDR Text Key: 251148862
• Report Number: 2125050-2021-00543
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• 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
• Device Lot Number: 5159761
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention