MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH

Catalog Number 720093-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 05/12/2015

Event Type  Injury  

Event Description

It was reported that following the implantation of an elevate anterior graft the patient presented with a moderate "labial infection." the patient "experienced pain and asymmetry of perineal body; no fever, no extension of tenderness into vagina.Likely stitch abscess." medication was administered on (b)(6) 2015.The event is not recovered/not resolved (continuing).There were no further patient complications reported as a result of this event.

Event Description

Additional information received indicated that the patient was evaluated at an unscheduled office visit, "symptoms continue; no improve.Suspect inflamed bulbocavernous muscle." additional medication and "trigger point injection" was administered on (b)(6) 2015.The event was considered not recovered/not resolved (continuing).Additional evaluation revealed "less pain since trigger point injection; upon exam pain in small area of granulation tissue to 6 o'clock at the introitus" silver nitrate was applied on (b)(6) 2015 and the event is considered recovering/resolving (adverse event is improving).There were no further patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received indicated that the event was considered resolved/recovered with no sequelae on (b)(6) 2015.If additional information is received, a follow up report will be sent.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• Type of Device: SURGICAL MESH
• 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: 4779176
• MDR Text Key: 5782248
• Report Number: 2183959-2015-00195
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,health professional,stu
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2018
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 05/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/20/2015; 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2015
• 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): Required Intervention