MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS INTEPRO Y-MESH; MESH, SURGICAL, POLYMERIC

Catalog Number 72404000

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Emotional Changes (1831); Fever (1858); Incontinence (1928); Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Vomiting (2144); Discharge (2225); Urinary Frequency (2275); Obstruction/Occlusion (2422); Prolapse (2475); Blood Loss (2597); Abdominal Distention (2601); Dysuria (2684)

Event Date 05/03/2005

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced fever, nausea, vomiting, cystitis, bowel obstruction, abdominal distention, suicidal ideation and attempts, atrophic vaginitis, heavy discharge with bad odor, bleeding, pain, rectocele, urgency, frequency, mild dysuria, urinary tract infection, insomnia, urinary retention, and urinary incontinence.It was also reported that the plaintiff allegedly experienced vaginal scarring, organ perforation, recurrence, emotional distress and a product problem.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to mfr report #: 2183959-2014-51009.Related to mfr report #: 2183959-2014-51135.Related to mfr report #: 2183959-2014-49169.Related to mfr report #: 2183959-2014-51002.Related to mfr report #: 2183959-2014-51146.

Manufacturer Narrative

(b)(4).Lawyer-filed report.

• Brand Name: AMS INTEPRO Y-MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn, dir qlty compliance ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4920766
• MDR Text Key: 22240671
• Report Number: 2183959-2014-51104
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033636
• 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: 06/05/2013

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
• Device Expiration Date: 12/22/2005
• Device Catalogue Number: 72404000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2013
• Initial Date FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2004
• 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: INTEXEN; INFAST AND INTEXEN; UNKNOWN GRAFT AND INTEPRO Y-MESH
• Patient Outcome(s): Death
• Patient Age: 39 YR
• Patient Weight: 75