MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

Model Number PCDG1

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fistula (1862); Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544)

Event Date 03/01/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4)   a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.If further details are received at a later date a supplemental medwatch will be sent. .

Event Description

It was reported that a patient underwent a midline laparotomy abdominal hernia repair on an unknown date and the mesh was implanted.It was reported that the mesh disintegrated and continually caused infection creating sinuses and fistulas.There was an attempt to remove the device, but because it was in poor condition and parts had migrated, it was impossible to remove.It has continued to cause infection on a regular fortnightly basis for the last 5 years, since its attempted removal in (b)(6) 2016.It was also reported that the patient has been unable to sit for any period, has constant and chronic infections, has long periods in bed, has been unable to drive, and has been unable to walk any distances when infection is occurring.It was reported that since the mesh was implanted the patient suffered ongoing pain, infections, had been hospitalized for weeks at a time, and been told it could not be the surgical mesh causing the problem.The patient's 30 year old caesar scan opened displaying the mesh which had migrated to that area.The patient was immediately transferred in an attempt to remove the mesh.The patient has been admitted into palliative care for 18 months to control the pain, and been discharged from this program after 18 months.The patient has seen numerous doctors and specialists for alternative support and have more recently been under the chronic pain team.The patient has been given ordine and methadone for the last 20 months.No further information was available.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11823940
• MDR Text Key: 265137739
• Report Number: 2210968-2021-04626
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047716
• UDI-Public: 10705031047716
• Combination Product (y/n): N
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: PCDG1
• Device Catalogue Number: PCDG1
• Device Lot Number: BLG547
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention