MAUDE Adverse Event Report: ETHICON GYNECARE TVT MESH

Lot Number LOG593580

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Bacterial Infection (1735); Fever (1858); Unspecified Infection (1930); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 04/25/2016

Event Type  Injury  

Event Description

Alloderm from lifecell was implanted to support vaginal tissue and mesh was inserted to support my bladder.One week after implants were placed, i got very ill with fever.It was finally discovered i had contracted to drug resistant infection, pseudomonas from the implants.I did an outpatient iv antibiotic treatment, but remained ill.Saw infectious disease dr and he felt the bacteria colonized in the tissue and mesh.Got a second opinion and was told the implants needed to come out.I did have to have them removed to get well.The tvt mesh embedded in my bladder wall, urethra, and anus.I am still in pain, but these products should never be used again.I had 8 corrective surgeries to help me get better.After removal, the pseudomonas returned.Again, outpatient antibiotic therapy.This should happen to no one."how was it taken or used: vaginal.Date the person first started taking or using the product: (b)(6) 2016, date the person stopped taking or using the product: (b)(6) 2017."did the problem stop after the person reduced the dose or stopped taking or using the product: no, did the problem return if the person started taking or using the product again: doesn't apply." it was suppose to support vaginal tissue, bladder prolapse.

• Brand Name: GYNECARE TVT MESH
• Type of Device: GYNECARE TVT MESH
• Manufacturer (Section D): ETHICON
• MDR Report Key: 7074893
• MDR Text Key: 93604411
• Report Number: MW5073670
• Device Sequence Number: 2
• Product Code: OTN
• 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: 11/27/2017

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: No Information
• Device Expiration Date: 04/25/2016
• Device Lot Number: LOG593580
• Other Device ID Number: 610041B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR