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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON JOHNSON AND JOHNSON PROSIMA
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ETHICON JOHNSON AND JOHNSON PROSIMA Back to Search Results
Device Problem Extrusion (2934)
Patient Problems Abdominal Pain (1685); Erosion (1750); Muscle Spasm(s) (1966); Pain (1994); Urinary Tract Infection (2120)
Event Date 02/01/2013
Event Type  No Answer Provided  
Event Description
I was implanted with the prosima ethicon transvaginal mesh on (b)(6) 2011.Approximately (b)(6) 2013, i began having numerous bladder infections, painful intercourse, pelvic pain, vaginal spasms and smelly urine.I am a teacher and felt like i needed to rest and would be fine.When nothing changed, i wasn't able to get an appt with my nurse practitioner until (b)(6) 2014.I described my issues and she did a thorough exam.She felt the mesh and immediately called in the gynecologist, who had performed the surgery, and he also felt the mesh protruding though the vaginal wall.He started me on estrogen cream.I then was referred by my primary care physician to a urologist who did a bladder scope and a thorough vaginal exam.He agreed the mesh was protruding through the vaginal wall and referred me to (b)(6).I did research and decided (b)(6) is my best hope for possibly correcting this horrific medical error and will meet for a consultation with dr (b)(6).
 
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Brand Name
PROSIMA
Type of Device
PROSIMA
Manufacturer (Section D)
ETHICON JOHNSON AND JOHNSON
MDR Report Key3692939
MDR Text Key4243659
Report NumberMW5035059
Device Sequence Number1
Product Code OTP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/16/2014
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? Yes
Device Operator Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/18/2014
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age54 YR
Patient Weight57
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