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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON JOHNSON AND JOHNSON PYHSIOMESH PHYSIOMESH

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ETHICON JOHNSON AND JOHNSON PYHSIOMESH PHYSIOMESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Arthritis (1723); Pain (1994); Disability (2371); Ambulation Difficulties (2544)
Event Date 10/12/2011
Event Type  Injury  
Event Description
On (b)(6) 2011 ventral incisional hernia using 30 x 35 ethicon physiomesh sent to pain management. Six weeks later due to continuing to serious pain. On (b)(6) 2014 rushed to er: due to incarcerated loop of small bowel within ventral hernia, and replaced the physiomesh with the same. This has ruined my life, i have had to go to pain management for 7 years, i can barely walk and now diagnosed with psoriatic arthritis. I have been on disability since (b)(6) 2012.
 
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Brand NamePYHSIOMESH
Type of DevicePHYSIOMESH
Manufacturer (Section D)
ETHICON JOHNSON AND JOHNSON
MDR Report Key6348757
MDR Text Key68106290
Report NumberMW5067990
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/18/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/18/2017
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/18/2017 Patient Sequence Number: 1
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