MAUDE Adverse Event Report: COLOPLAST CORP., / J & J DEPUY ORTHO MESH TVT SLING BLU

Model Number 81004IB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Emotional Changes (1831); Incontinence (1928); Nerve Damage (1979); Pain (1994); Scarring (2061); Malaise (2359)

Event Date 01/18/2018

Event Type  Injury  

Event Description

I had pelvic organ prolapse surgery with restorelle mesh implantation done abdominally and tvt sling by dr (b)(6) at (b)(6) medical center.I have debilitating pain, feel very sick all of the time, full fecal incontinence (which i never had once in my life until this surgery, it started immediately following this surgery), i am unable to have intercourse due to terrible pain, have had mesh revision surgery at (b)(6) by dr (b)(6) where mesh was found to have ended completely through.I have had trigger point injections of steroids to try to break down scar tissue that has formed and long lasting numbing medicine, and have add'l mesh revision surgery scheduled in july.I have permanent nerve damage and terrible burning pain in my pelvis 100% of the time.I went from being a healthy active woman, single mother of two, with an 18 year career, to being in constant pain, unable to do much of anything at all, unable to have an intimate relationship, unable to work, this mesh has taken my life from me.Mesh exposure, dyspareunia.Fda safety report id# (b)(4).

• Brand Name: MESH TVT SLING BLU
• Type of Device: MESH TVT SLING BLU
• Manufacturer (Section D): COLOPLAST CORP., / J & J DEPUY ORTHO
• MDR Report Key: 8691836
• MDR Text Key: 147945784
• Report Number: MW5087276
• Device Sequence Number: 2
• Product Code: PAH
• 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: 06/09/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 81004IB
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 44 YR
• Patient Weight: 61