MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS ELEVATE (NOT SPECIFIED); MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Death (1802); Disseminated Intravascular Coagulation (DIC) (1813); Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Pneumonia (2011); Scarring (2061); Sepsis (2067); Chronic Obstructive Pulmonary Disease (COPD) (2237); Blood Loss (2597)

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated 08/30/2014 under exemption (b)(4).

Event Description

It was reported by the plaintiff¿s attorney that the plaintiff allegedly experienced pain, infection, urinary problems, bowel problems, recurrence, bleeding, neuromuscular problems, vaginal scarring, emotional distress and a product problem.The mesh remains implanted.Furthermore, it was reported that the plaintiff died.The causes of death were reported as disseminated intravascular coagulation, sepsis, bilateral pneumonia, chron¿s colitis, liver failure, chronic obstructive pulmonary disease and anemia.Related to manufacturer report #: 3011770902-2016-00337, 3011770902-2016-00338.

• Brand Name: AMS ELEVATE (NOT SPECIFIED)
• Type of Device: MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE
• 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: randy hoyt ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5840930
• MDR Text Key: 50957386
• Report Number: 3011770902-2016-00336
• 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
• Type of Report: Initial
• Report Date: 07/05/2013

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
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/02/2016
• 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: ELEVATE ANTERIOR
• Patient Outcome(s): Death