MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC ALTIS KIT; SURGICAL MESH

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Neuropathy (1983); Pain (1994); Weakness (2145); Tingling (2171); Numbness (2415)

Event Date 10/01/2013

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the information received, patient's legal representation states that on (b)(6) 2013 patient was implanted with five competitor slings and one altis sling.Later, patient began feeling pain and neuropathy in her pelvic area, buttock, and along her left leg.Physician believed this pain was being caused by the competitors product and removed one of the competitor's slings on (b)(6) 2013.Patient continued to experience severe pain, tingling, and numbness in her pelvic and left lower regions.On (b)(6) 2014 patient underwent surgery to remove the remaining competitor product in her body.No indication that the altis sling was ever removed.Patient now lives with chronic pain, numbness and weakness in her lower body, and will continue to do so for life.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5363554
• MDR Text Key: 35797520
• Report Number: 2125050-2016-00003
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5196502400
• Device Catalogue Number: 5196502400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other