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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Micturition Urgency (1871); Incontinence (1928)

Event Type  Injury  

Event Description

As reported to coloplast though not verified, patient was implanted with coloplast altis mesh.Later the patient experienced intrinsic sphincter deficiency and intractable urgency incontinence; a cystoscopy and 4 durasphere injections were performed and a first state interstim implant was performed.

Manufacturer Narrative

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

• Brand Name: ALTIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam-1; humlebaek 3050, dk
• Manufacturer (Section G): COLOPLAST MANUFACTURING US LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: angela killian - head of ra ; 1601 west river road north; minneapolis, MN 55411 ; 6122874236
• MDR Report Key: 4400113
• MDR Text Key: 5305023
• Report Number: 2125050-2015-00001
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• 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: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention