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

Model Number 5196502400

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Incontinence (1928); Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

As reported to coloplast though not verified, patient was implanted with coloplast altis mesh.Later the patient experienced incontinence occurring more frequently at night and urinary tract infection.Vesicare, myrbetriq, bladder botox and antibiotics were prescribed.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report provides additional verbiage to the event description.

Event Description

As reported to coloplast though not verified, patient's legal representative stated patient was implanted with coloplast altis mesh.Later the patient experienced incontinence occurring more frequently at night and urinary tract infection.Vesicare, myrbetriq, bladder botox and antibiotics were prescribed.

• Brand Name: ALTIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek 3050, dk; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: janell colley ; 1601 west river road north; minneapolis, MN 55411 ; 6122874237
• MDR Report Key: 4975676
• MDR Text Key: 15234790
• Report Number: 2125050-2015-00079
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 12/16/2015

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: Physician
• Device Expiration Date: 04/30/2016
• Device Model Number: 5196502400
• Device Catalogue Number: 5196502400
• Device Lot Number: 3616248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2015
• Initial Date FDA Received: 08/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR