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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Unspecified Infection (1930); Vomiting (2144); Cramp(s) (2193); Hernia (2240); Blood Loss (2597); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unspecified hernia procedure on an unknown date and mesh was implanted.It was reported by the patient that following the procedure, the surgical wound reopened as the patient was being driven home, approximately an hour after being released from the hospital.The patient then reports that he continued to bleed for approximately two weeks before the wound began to clot.The patient went to a local medical clinic about one week after the surgery.The patient also had an x-ray taken approximately one month after the surgery where they found one golf ball-sized cyst and one marble-sized cyst, as well as an infection, at the surgical site.At a post-operative visit, the nurse practitioner swabbed the patient's wound and found it positive for infection and recommended that he go to the emergency room at the local hospital.The patient was not seen in the er.The patient saw his established cardiologist who tested his blood count and found no abnormalities.The cardiologist then recommended the patient to another surgeon who performed a revision surgery for the patient's hernia.The revision was performed approximately eight months after the original surgery.Before and after the revision surgery, the patient has been experiencing abdominal pain, cramping, "gas-like" pain, reduced appetite, and vomiting of food if the food is not eaten slowly, in small amounts, and with an ice pack on his stomach while eating.The patient has taken hydrocodone to manage the pain, but does not take it frequently as to not become dependent on it.Additional information will be requested.

• 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 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7337506
• MDR Text Key: 102329346
• Report Number: 2210968-2018-71426
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2018
• 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