MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC UNKNOWN SLING

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Calcium Deposits/Calcification (1758); Death (1802); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Sleep Dysfunction (2517); Dysuria (2684)

Event Date 06/30/2006

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced urinary retention, urethral calcification, yeast infection, left flank discomfort, erosion, persistent mixed incontinence, hesitancy, dysuria, urgency and frequency, urinary tract infection, recurrent cystitis, nocturia, and vaginal discharge.The mesh remains implanted.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to manufacturer report #: 3011770902-2016-00242, 3011770902-2016-00241.

• Brand Name: UNKNOWN SLING
• Type of Device: UNKNOWN
• 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: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5660299
• MDR Text Key: 45344170
• Report Number: 3011770902-2016-00240
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• 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: 06/24/2014

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: 05/03/2016
• Initial Date FDA Received: 05/17/2016
• 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: INFAST
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 70