MAUDE Adverse Event Report: ALLERGAN INC. / LIFECELL CORP LIFE CELL STRATTICE MESH; MESH, SURGICAL

Device Problem Leak/Splash (1354)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 06/02/2015

Event Type  Injury  

Event Description

Surgery to correct a mesh from about 2000, replaced with life cell strattice.After surgery, i stopped breathing and ended up on a ventilator for about 4 days.Spent about 6 days in the hosp after released within the first week i noticed infection where one port was placed for drainage and also in the incision.Had gone to the drs for f/u they basically ignore the situation.The infection was getting worse and deeper.This time i had gone to see my general physician and she sent me straight to the hosp due to the infection, then i was admitted for about 3 days.I had been sent home even after surgeons try to cut some of the infections out, basically, they scrapped them.Went to other dr appt's, after a period i ended up going to the er because of the drainage.This time i was quarantined in a room for a couple of days then the surgeon came in and said that they are going to do surgery again to cut the infections out completely.They did and left my stomach area with 2 flaps hanging and scars that are unbearable.I have now a continuing skin rash leaking out some kind of infection.I have been to my general physician and a dermatologist.They have treated me with several different medications and lotions, of course, none that worked.To this day i am still having problems of leakage and with the scans underneath the skin where operated on, feel pains when i twist or turn different ways and very painful.

• Brand Name: LIFE CELL STRATTICE MESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ALLERGAN INC. / LIFECELL CORP
• MDR Report Key: 8277694
• MDR Text Key: 134305270
• Report Number: MW5083363
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 57 YR
• Patient Weight: 66