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

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

Patient Problems Bleeding (1738); Unspecified Infection (1930); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported that a patient underwent a recurrent hernia repair procedure on (b)(6) 2008.A sinus was noted in the wound and infection was indicated in (b)(6) 2008.A discharging sinus was still noted in (b)(6) 2009 and the patient was experiencing abdominal pain and discharge and antibiotics were prescribed.The patient was admitted to the hospital.Wound infection along the site of the mesh was confirmed and treated.In (b)(6) 2009, removal of infected mesh and repair was performed.The patient was readmitted in (b)(6) 2009 with wound pain, bleeding and wound breakdown and was treated.The patient was admitted in (b)(6) 2010 with a painful, fluid filled lump around the operation scar.No additional information was provided.

Manufacturer Narrative

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

• Brand Name: ETHICON MESH UNKNOWN
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3595181
• MDR Text Key: 4187216
• Report Number: 2210968-2014-01119
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• 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: 01/09/2014
• 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