MAUDE Adverse Event Report: ETHICON INC. PROLENE HERNIA SYSTEM MESH

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Fever (1858); Unspecified Infection (1930); Septic Shock (2068); Surgical procedure (2357); Treatment with medication(s) (2571)

Event Date 02/07/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent a breast mound reconstruction tram flap surgery along with hernia prevention procedure on (b)(6) 2012 and mesh was implanted.Following the procedure, the patient started feeling sick on (b)(6) 2012 and experienced a high fever with severe septic shock on (b)(6) 2012.It was also reported that the patient experienced septic infections several times within 15 months, multiple hospitalizations and icu admissions.The physician opines that repeated septic infections were developed due to infection was trapped in the mesh.The patient underwent additional surgeries to clean up infections and remove the mesh.As per patient, a small section of mesh remains in the body because it has been integrated too far into vascular system to remove it safely.The patient receives a long term prophylactic antibiotics therapy.Additional information has been requested.

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.This medwatch report is in response to receipt of maude event report mw5042570.

• Brand Name: PROLENE HERNIA SYSTEM MESH
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4965878
• MDR Text Key: 6329192
• Report Number: 2210968-2015-10845
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Weight: 82