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

Device Problems Fire (1245); Insufficient Information (3190)

Patient Problems Death (1802); Injury (2348)

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff died.The cause of death reported was blunt and thermal trauma due to single motor vehicle accident with post crash fire.

Manufacturer Narrative

Additional information: the device subject to litigation was an implantable vaginal mesh.Information provided is not sufficient to identify the specific brand or common name.If additional information is received, a follow up report will be sent.

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced an unspecified injury and product problem.The device remains implanted.No further patient complications have been reported in relation to this event.Furthermore, it was reported that the plaintiff died due to blunt and thermal trauma from a single motor vehicle accident with post crash fire.

• Brand Name: UNKNOWN
• Type of Device: NA
• 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: 5567880
• MDR Text Key: 42355313
• Report Number: 3011770902-2016-00165
• Device Sequence Number: 1
• Product Code: OTP
• 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,Followup
• Report Date: 04/06/2016
• 2 Devices were Involved in the Event: 1 2

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2016
• 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
• Patient Outcome(s): Death