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

Catalog Number 72403885

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Death (1802); Emotional Changes (1831); Incontinence (1928); Internal Organ Perforation (1987); Pain (1994); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Discharge (2225); Prolapse (2475); Blood Loss (2597)

Event Date 09/14/2004

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced recurrent pelvic prolapse and urinary incontinence, urinary retention, atrophic vaginitis, heavy discharge with bad odor, bleeding, urinary retention, urinary tract infection, intrinsic sphincter dysfunction, rectocele, cystocele, left flank pain, pelvic pain, abdominal pain, and bladder pain.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 #: 2183959-2014-51135.Related to mfr report #: 2183959-2014-49169.Related to mfr report #: 2183959-2014-51002.Related to mfr report #: 2183959-2014-51104.Related to mfr report #: 2183959-2014-51146.

Manufacturer Narrative

(b)(4).

• 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 zurn, dir qlty compliance ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4920783
• MDR Text Key: 6009070
• Report Number: 2183959-2014-51009
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 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
• Device Expiration Date: 03/01/2005
• Device Catalogue Number: 72403885
• 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
• Date Device Manufactured: 03/01/2004
• 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
• Patient Outcome(s): Death
• Patient Age: 38 YR
• Patient Weight: 75