MAUDE Adverse Event Report: ETHICON INC. PROCLEAN FLAT MESH; MESH, SURGICAL, POLYMERIC

Model Number CJE467

Device Problems Break (1069); Crack (1135)

Patient Problems Pain (1994); Vomiting (2144)

Event Date 04/05/2019

Event Type  Injury  

Event Description

Had hernia surgery in 2011 and after a couple of years my teeth began to crack and break until i was toothless then eventually my stomach started having pains until i started vomiting all night every night until it became uncontrollable.I eventually was rushed to the hosp where they elected to do emergency surgery and found that the mesh had become gangrenous.I had an add'l surgery with the next week and was placed in medically induced coma for nearly 3 months and after they brought me back, i was in the hosp for an add'l 3 months.Eventually i got a fistula which resulted in 2 years of hospitalization and too much stress on my heart; finally after getting strong enough to finish my journey to getting better, i had 2 more surgeries this year as a result of this mesh.Fda safety report id# (b)(4).

• Brand Name: PROCLEAN FLAT MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.
• MDR Report Key: 8604662
• MDR Text Key: 145006661
• Report Number: MW5086570
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/08/2019
• Device Model Number: CJE467
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 66