MAUDE Adverse Event Report: ATRIUM MEDICAL VITA MESH ; POLYPROPYLENE MESH

Model Number PPVF

Device Problem Material Fragmentation (1261)

Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994)

Event Date 03/10/2015

Event Type  Injury  

Event Description

I had an atrium medical vitamesh polypropylene cat #ppvf3030, i have had 9 open surgeries, my mesh is crumbling.I was a healthy (b)(6) woman, now i am told i can't return, to my job as a hospital tech i can't work in and out of hospital, chronic pain, adhesion, blockage in small bowel, erosion.It has destroyed my life, seeing 9 different doctors.Lost everything as well as my job.(b)(6).

• Brand Name: VITA MESH
• Type of Device: POLYPROPYLENE MESH
• Manufacturer (Section D): ATRIUM MEDICAL
• MDR Report Key: 6717361
• MDR Text Key: 80300523
• Report Number: MW5071008
• Device Sequence Number: 1
• Product Code: FTL
• 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: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: PPVF
• Device Catalogue Number: 3030
• Device Lot Number: 3030
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 48 YR
• Patient Weight: 59