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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON PHYSIO MESH

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ETHICON PHYSIO MESH Back to Search Results
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.
 
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Brand NamePHYSIO MESH
Type of DeviceMESH
Manufacturer (Section D)
ETHICON
MDR Report Key6092133
MDR Text Key59766213
Report NumberMW5065929
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
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 Received11/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/08/2016 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
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