MAUDE Adverse Event Report: COLOPLAST ALTUS SINGLE INCISION SLING

Model Number ALTIS

Device Problems Material Erosion (1214); Malposition of Device (2616)

Patient Problems Nausea (1970); Pain (1994); Burning Sensation (2146); Complaint, Ill-Defined (2331); Sweating (2444)

Event Date 03/25/2015

Event Type  Injury  

Event Description

Altis single incision sling implanted (b)(6) 2013.Sex was always painful after implant.About 1 year after implant, began having constant aching and burning in pelvic area.In (b)(6) 2015, severe pain in pelvic pubic vaginal area lead to seeing urologist where it was discovered the mesh had mal-positioned and began eroding into vaginal wall.Surgery to correct done on (b)(6) 2015; 1.5 cm of sling was removed.Since surgery, even more severe pelvic and vaginal pain.Can still feel a tight band across vaginal canal.Aching along pubic bone and into groin and rt leg.Severe pain when bladder seems to be full but when i urinate in only go a little.Constant nausea and night sweats.

• Brand Name: ALTUS SINGLE INCISION SLING
• Type of Device: ALTUS SINGLE INCISION SLING
• Manufacturer (Section D): COLOPLAST; SW
• MDR Report Key: 4749706
• MDR Text Key: 5706615
• Report Number: MW5042478
• 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
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2016
• Device Model Number: ALTIS
• Device Lot Number: 3616248
• Patient Sequence Number: 1
• Treatment: VALTEX 500 MG; VESICARE 5 MG; CIPRO 500 MG; LINZESS 290 MCG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 46