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

Model Number 5196502400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Pain (1994); Swelling (2091); Therapeutic Response, Decreased (2271); Prolapse (2475); No Code Available (3191)

Event Date 04/04/2014

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Response in field is because device was not explanted or returned.Device not explanted or returned.

Event Description

As reported to coloplast though not verified, patient was implanted with altis mesh.Later the patient experienced feeling a bulge, recurrent prolapse, cystocele, incontinence, suprapubic pain, worsening right sided lower abdominal pain and spigelian hernia.Vesicare, bladder retraining and bladder diet were prescribed and an attempt to fit pessary was unsuccessful.An incisional hernia repair with mesh, right flank was performed.

Manufacturer Narrative

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

Event Description

Patient's legal representative stated though not verified, patient was implanted with altis mesh.Later the patient experienced feeling a bulge, recurrent prolapse, cystocele, incontinence, suprapubic pain, worsening right sided lower abdominal pain and spigelian hernia.Vesicare, bladder retraining and bladder diet were prescribed and an attempt to fit pessary was unsuccessful.An incisional hernia repair with mesh, right flank was performed.

• Brand Name: ALTIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da MN 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: 5025268
• MDR Text Key: 23864814
• Report Number: 2125050-2015-00084
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR