MAUDE Adverse Event Report: TAH BSO MONARCH SLING; SURGICAL MESH

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Depression (2361); Weight Changes (2607)

Event Date 06/11/2014

Event Type  Injury  

Event Description

In 2008, i was hospitalized at (b)(6) for surgery due to bladder prolapse.I also had a total hysterectomy.I was told by my doctor (b)(6) that i would be feeling better in no time.My first shocker was painful sex with my now ex-husband.When i tried to get back to my active lifestyle, working out and exercise, i experience severe pelvic pain.I have frequency infections, chronic pelvic pain, depression from weight gain and all around lost in the quality of my life.I am constantly in pain whether i am sitting, standing or laying down.My health is going downhill since the surgery and implant device.I called my dr to request it be removed and they would not do it; fearing it would cause worst damage.I am devastated and alone at (b)(6) old.

• Brand Name: TAH BSO MONARCH SLING
• Type of Device: SURGICAL MESH
• MDR Report Key: 3880271
• MDR Text Key: 4591568
• Report Number: MW5036643
• Device Sequence Number: 1
• Product Code: OTN
• 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: 06/12/2014

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 50 YR
• Patient Weight: 100