MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS ELEVATE (NOT SPECIFIED); SURGICAL MESH

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Incontinence (1928)

Event Date 09/22/2014

Event Type  Injury  

Manufacturer Narrative

The device was implanted (b)(6) 2010.

Event Description

It was reported that after an elevate was implanted, the patient experienced mesh erosion and persistent stress incontinence.It was noted that the device malfunctioned.The patient underwent mesh removal on (b)(6) 2012, (b)(6) 2012 and (b)(6) 2014.The patient was discharged.No further patient complications were reported in relation to this event.Related to manufacturer report #: 3011770902-2015-00113 related to manufacturer report #: 3011770902-2015-00115.

• Brand Name: AMS ELEVATE (NOT SPECIFIED)
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): ASTORA WOMEN'S HEALTH LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer (Section G): ASTORA WOMEN'S HEALTH LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer Contact: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5335963
• MDR Text Key: 34707842
• Report Number: 3011770902-2015-00114
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2015

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PERIGEE
• Patient Outcome(s): Hospitalization; Required Intervention