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U.S. Department of Health and Human Services

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

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TAH BSO MONARCH SLING; SURGICAL MESH Back to Search Results
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.
 
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Brand Name
TAH BSO MONARCH SLING
Type of Device
SURGICAL MESH
MDR Report Key3880271
MDR Text Key4591568
Report NumberMW5036643
Device Sequence Number1
Product Code OTN
Reporter Country CodeUS
Number of Events Reported1
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 Received06/13/2014
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Disability;
Patient Age50 YR
Patient Weight100
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