MAUDE Adverse Event Report: ETHICON INC. PROCEED* MULTI-LAYER LAMINATE MESH; MESH, SURGICAL, POLYMERIC

Catalog Number PCDL1

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Fistula (1862); Incontinence (1928); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Internal Organ Perforation (1987); Scar Tissue (2060); Urinary Tract Infection (2120); Cramp(s) (2193); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Event Description

It was reported by an attorney that the patient underwent a hernia repair on (b)(6) 2010 due to ventral hernia x 4, sui, and pop, and a hernia mesh was used.It was reported that following insertion the patient experienced pain, erosion, extrusion, infection, urinary/bowel problems, organ perforation, fistulae, recurrence, bleeding, dyspareunia, neuromuscular problems and vaginal scarring.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 3/29/2016 it was reported that the patient underwent a gynecological procedure on (b)(6) 2010 and mesh was implanted due to ventral hernia repair.It was reported that patient underwent right nephrectomy on (b)(6) 2009 due to recurrent kidney stones and right flank pain.No additional information was provided.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

(b)(4).It was reported that following insertion the patient experienced abdominal pain and cramping, painful sexual intercourse, urinary problems and recurrent utis resulting in self-catherizing.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5498535
• MDR Text Key: 40256407
• Report Number: 2210968-2016-06214
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: PCDL1
• Device Lot Number: BKG454
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 65