MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS MONARC; MESH, SURGICAL, GYNECOLOGIC

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

Patient Problems Pain (1994); Dysuria (2684); Patient Problem/Medical Problem (2688)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

Preoperative diagnoses: vaginal mesh located in the bladder neck, dysuria, pelvic pain, and stone encrustation on mesh.Postoperative diagnosis: same.Procedure: cystoscopy, bilateral ureteric catheterization, excision of mesh via the vagina using an open cystotomy, urethroplasty and martius flaps.

• Brand Name: MONARC
• Type of Device: MESH, SURGICAL, GYNECOLOGIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS; 10700 bren road west; minnetonka, MI 55343
• MDR Report Key: 5083693
• MDR Text Key: 26017198
• Report Number: 5083693
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 06/25/2015,08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR