MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. INFAST SLING; MESH, SURGICAL, POLYMERIC

Catalog Number 78352200

Device Problem Extrusion (2934)

Patient Problems Death (1802); Pain (1994); Discomfort (2330)

Event Date 04/14/2008

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced retropubic pain and discomfort, and protrusion.Furthermore, it was reported that the plaintiff died.The cause of death was reported as colon cancer.

Manufacturer Narrative

This was initially reported on the summary report dated (b)(6), 2014 under exemption (b)(4).Lawyer-filed report.

• Brand Name: INFAST SLING
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: sharon zur, director ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4817670
• MDR Text Key: 5902840
• Report Number: 2183959-2014-71694
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K011910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 78352200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 67 YR