MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. UNKNOWN GRAFT MESH

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Emotional Changes (1831); Incontinence (1928); Internal Organ Perforation (1987); Pain (1994); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Discharge (2225); Urinary Frequency (2275); Prolapse (2475); Blood Loss (2597); Dysuria (2684)

Event Date 02/21/2005

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced urinary incontinence, urinary retention, atrophic vaginitis, heavy discharge with bad odor, bleeding, rectocele, urgency, frequency, mild dysuria, urinary tract infection, insomnia, pelvic prolapsed, left flank/bladder/pelvic pain, intrinsic sphincter dysfunction, and cystitis.It was also reported that the plaintiff allegedly experienced dyspareunia, vaginal scarring, organ perforation, 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 #: 2183959-2014-51104.Related to mfr report #: 2183959-2014-51146.

Manufacturer Narrative

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

• Brand Name: UNKNOWN GRAFT MESH
• Type of Device: NA
• 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: 4920784
• MDR Text Key: 21330629
• Report Number: 2183959-2014-51002
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Date FDA Received: 07/15/2015
• 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?: No
• Date Manufacturer Received: 06/05/2013
• 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: INFAST; INTEPRO Y-MESH; INTEXEN
• Patient Outcome(s): Death
• Patient Age: 38 YR
• Patient Weight: 75