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

Model Number 5195512400

Device Problem Missing Information (4053)

Patient Problems Erosion (1750); Pain (1994); Intermenstrual Bleeding (2665)

Event Date 01/01/2012

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.

Event Description

As reported to coloplast, though not verified, reported per end user: "hello, i had surgery to help with my urinary incontinence in 2010.In 2012, i had to go back to the doctor since a portion of the strip was visible outside my vagina.The doctor cut off the end and send to the lab.The result is that an erosion set in, which is why i cannot have sex.Penetration is very painful and causes bleeding.I have had this strip for 10 years now and the problems do not go away, but they are more and more present.I recently started having trouble sitting, groin pain during the night and the pain on either side is almost permanent.I wonder if your device is involved and what should i do to fix it?".

Event Description

This follow-up mdr is created to document the additional event information received for record (b)(4).According to the available information the date of the aris procedure was in 2010.Information received from the end user indicated: ¿hello, i had a surgery to help with my urinary incontinence in 2010.In 2012, i had to go back to the doctor since a portion of the strip was visible outside my vagina.The doctor cut off the end and send to the lab.The result is that an erosion set in, which is why i cannot have sex.Penetration is very painful and causes bleeding.I have had this strip for 10 years now and the problems do not go away, but they are more and more present.I recently started having trouble sitting, groin pain during the night and the pain on either side is almost permanent.I wonder if your device is involved and what should i do to fix it?" no components were received for evaluation as it remains implanted.As examination of the components may not conclusively confirm or disprove the report of erosion quality accepts the physician¿s observations as to the reason for surgical intervention.As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

Manufacturer Narrative

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• 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: 10604109
• MDR Text Key: 209136428
• Report Number: 2125050-2020-00901
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 08/30/2020
• Supplement Dates FDA Received: 10/20/2020
• Patient Sequence Number: 1