MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURGICAL MESH

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Scarring (2061); Deformity/ Disfigurement (2360)

Event Date 08/31/2015

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 of 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, patient's legal representative stated pelvic pain, urinary urgency, urinary incontinence, permanent and substantial physical deformity, the loss of the ability to perform sexually, severe erosion of the vaginal wall and other tissues, infection, scarring, disfigurement.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• 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: 6883813
• MDR Text Key: 87160193
• Report Number: 2125050-2017-00454
• 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: other
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• 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
• Device Lot Number: 4060195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other