MAUDE Adverse Event Report: SURGICAL MESH FOR BLADDER PROLAPSE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Break (1069)

Patient Problem Purulent Discharge (1812)

Event Date 03/11/2013

Event Type  Injury  

Event Description

I was having blood appear on pads regularly.(i had a total hysterectomy many years ago.) the np found what she thought was a blue stitch deep in the vaginal canal.A couple of days later, the surgeon who had done the 2013 surgery scheduled a medical procedure to correct the problem.A few months later, i began having an almost constant urine colored vaginal discharge.On (b)(6) 2013 abdominal surgery to correct: 3rd degree cystocele, 3rd degree enterocele, 3rd degree rectocele, based on pelvic exam (b)(6) 2012.Severe rectal pain with every bm immediately following surgery and has continued.Bloody vaginal discharge became noticeable in 2018.A medical procedure on (b)(6) 2018 was performed to correct broken mesh.Another pelvic exam on (b)(6) 2018 found further vaginal trauma.I have chosen not to return to surgeon who performed surgery; (b)(6) 2013 the vaginal discharge sometimes has blood and fibrous looking "threads".Surgical mesh, used as a sling for bladder.Estimate duration: 6+ years.

• Brand Name: SURGICAL MESH FOR BLADDER PROLAPSE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• MDR Report Key: 8866515
• MDR Text Key: 153785732
• Report Number: MW5088847
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/23/2019

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: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 75