MAUDE Adverse Event Report: COLOPLAST ALTIS SINGLE INCISION SLING; MESH, STRESS URINARY INCONTINENCE

Catalog Number 519650

Device Problem Insufficient Information (3190)

Patient Problems Flatus (1865); Pain (1994); Swelling (2091); Urticaria (2278); Complaint, Ill-Defined (2331)

Event Type  No Answer Provided  

Event Description

Patient had sling implanted on (b)(6) 2016 due to stress urinary incontinence.Patient was told by her doctor that her life would be better with the sling.Patient is instead having issues with the sling.Patient experiences pain that shoots down her abdomen and leg, swollen feet, hives all over her body, abdomen bloating, bacteria in her mouth, gum disease, and swollen glands in neck and throat.Stiffness in ribcage and pelvic area.She feels that her breathing is restricted.Patient had a ct scan done and she was diagnosed as having diverticula.

• Brand Name: ALTIS SINGLE INCISION SLING
• Type of Device: MESH, STRESS URINARY INCONTINENCE
• Manufacturer (Section D): COLOPLAST
• MDR Report Key: 6338834
• MDR Text Key: 67824557
• Report Number: MW5067923
• Device Sequence Number: 1
• Product Code: PAH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/02/2019
• Device Catalogue Number: 519650
• Device Lot Number: 4933380
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 73