MAUDE Adverse Event Report: ETHICON PHYSIO MESH

Device Problem Entrapment of Device (1212)

Patient Problems Tissue Damage (2104); Vomiting (2144); Weakness (2145); Ambulation Difficulties (2544); Weight Changes (2607)

Event Date 11/13/2013

Event Type  Injury  

Event Description

Small intestine was caught in mesh.Doctor had to take out part of small intestine.I had 6 bottles of bile taken out of me.I was hospitalized for 7 days and lost (b)(6).Surgeon said it could happen again with time.Had none ahead of time.It started at home and wife rushed me to emergency room.I started throwing up green bile all over the place.I was so weak i could hardly move.Had all test done at emergency room.It was so bad doctor operated on me on a sunday.

• Brand Name: PHYSIO MESH
• Type of Device: MESH
• Manufacturer (Section D): ETHICON
• MDR Report Key: 6092133
• MDR Text Key: 59766213
• Report Number: MW5065929
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CODEINE.; GAVISCON.; HAD TO STOP HIS CELEBREX BECAUSE IT GAVE HIM ; KLONOPIN FOR SLEEP.; OTC MEDS: TUMS,; PEPTO BISMOL AND ; RX MEDS: ONLY MEDS HE CAN TAKE ARE TYLENOL WITH; STOMACH PROBLEMS. ; TUMS AND
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 83