MAUDE Adverse Event Report: JOHNSON & JOHNSON TRANSVAGINAL MESH SLING

Device Problem Insufficient Information (3190)

Patient Problems Dehydration (1807); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Itching Sensation (1943); Nausea (1970); Pain (1994); Swelling (2091); Thrombus (2101); Vomiting (2144); Dizziness (2194); Sweating (2444); Palpitations (2467)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

On the morning of (b)(6) 2014, i went to the er with nausea, vomiting, stomach, jaw pain, chest pain, itching, swelling of face, neck, arms left side from arm to feet, de-hydrated, high blood pressure.Was told to go and take aleve.Blood "colitis" in lungs, legs, arms.To whom it may concern: in the year 2007, i had a pelvic organ prolapse surgery done by (b)(6).He used mesh implant.On (b)(6) 2007, i have expressed abdominal pain, back pain, intercourse pain, urge incontinence, difficulty holding bowel movements, vaginal pressure, lump in vaginal opening, itchy.Had to have a seventh surgery still having problems.Night sweats more than normal, swelling of the stomach, tender to touch.Blood clots torn kidney.One ovary had two.Staple in stomach after the bladder tuck, had to return to er to repair scared kidney.I was placed in the hospital, had surgery back to back three times to put in splint.It was connected from my bladder to my kidney.After that, they let one splint remain in for 6 months that was very painful.After removal, i left better.I am still having problems back ache, a drainage swelling of the stomach, ankles.Just too much to tell.Swelling, lightheaded, heart beating fast, high blood 144/97/67 and drop to 97/73/77 back to 147/94/82.Unremovable, product fell, had to operate again on (b)(6) 2012.

• Brand Name: TRANSVAGINAL MESH SLING
• Type of Device: TRANSVAGINAL MESH SLING
• Manufacturer (Section D): JOHNSON & JOHNSON
• MDR Report Key: 4217251
• MDR Text Key: 14876157
• Report Number: MW5038881
• 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: Other
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2014
• Patient Sequence Number: 1
• Treatment: ZOLPIDEM 10MG; BENZONATATE 100MG; DULOXETINE HCL DR 60MG; BC AT TIMES; EXFORGE 10-160MG; PROMETHAZINE 25MG; PANTOPRAZOLE SOD DR 40MG; TRIMETHOPRIM 100MG
• Patient Outcome(s): Other
• Patient Age: 108 YR
• Patient Weight: 61