MAUDE Adverse Event Report: JOHNSON & JOHNSON ETHICON PHYSIOMESH

Model Number PHY1015V

Device Problem Nonstandard Device (1420)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Inflammation (1932); Ischemia (1942); Vomiting (2144); Complaint, Ill-Defined (2331); Obstruction/Occlusion (2422); Weight Changes (2607)

Event Date 10/03/2016

Event Type  Injury  

Event Description

In 2014, i had umbilical hernia repaired using ethicon physiomesh which has subsequently been recalled.An ed visit was made with a week or two after surgery for abdominal pain.On (b)(6) 2016, developed severe abdominal pain after eating.Went to ed, ct scan of abdomen showed partial small bowel obstruction.Admitted for observation, hydrated iv antibiotics and 5 days later required exploratory laparotomy.Surgical findings were acute and chronic inflammation, multiple adhesions, hemorrhage and ischemia in the small bowel.Open bowel resection 90 cm + of small bowel removed.Was on pca dilaudid for 4 days.Weight loss was 25 lbs.Discharged home for further workup.Pathology was negative for cancer.Gastric emptying negative.Mra negative.Upper endoscopy was negative.Unsure of reason.Still not feeling well with episodes of vomiting.Upon further research.I discovered the urgent field safety notice for the voluntary recall which i was never made aware of.I am further investigating as to whether or not there is a connection between the ethicon physiomesh and my experience.

• Brand Name: ETHICON PHYSIOMESH
• Type of Device: MESH
• Manufacturer (Section D): JOHNSON & JOHNSON
• MDR Report Key: 6106182
• MDR Text Key: 60281266
• Report Number: MW5066083
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PHY1015V
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 91