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

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Hematoma (1884); Hemorrhage/Bleeding (1888); Incontinence (1928); Muscle Spasm(s) (1966); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Complaint, Ill-Defined (2331)

Event Date 11/29/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to coloplast though not verified, patient was implanted with coloplast altis mesh.Later the patient experienced mid urethra wound with hematoma and associated pain, urinary retention, spasms, pain, continued and worsening pelvic pain, stress urinary incontinence, urinary tract infection with hematoma and an ovarian cyst.An exploration and evacuation of a 50 ml hematoma with cystoscopy were performed.There was active bleeding identified high underneath the pubic bone and was reduced with floseal and arista power.Pessary use was discussed and an ultrasound was performed.Antibiotics were prescribed.No explant procedure was reported.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam-1; humlebaek 3050, dk
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 w. river road n.; minneapolis MN 55411
• Manufacturer Contact: angela kilian-head of ra ; 1601 w. river road n.; minneapolis, MN 55411 ; 6122874236
• MDR Report Key: 4095367
• MDR Text Key: 21166793
• Report Number: 2125050-2014-00402
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 09/17/2014

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?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2015
• Device Model Number: 5196502400
• Device Catalogue Number: 5196502400
• Device Lot Number: 3428546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2012
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other