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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH MESH, SURGICAL

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JOHNSON AND JOHNSON ETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH MESH, SURGICAL Back to Search Results
Catalog Number PHY1015V
Device Problem Sticking (1597)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fever (1858); Pain (1994); Rash (2033); Weakness (2145); Discomfort (2330); Numbness (2415); Obstruction/Occlusion (2422); Ambulation Difficulties (2544); Weight Changes (2607)
Event Date 04/03/2017
Event Type  Injury  
Event Description
Symptoms started in (b)(6) 2016. Would wake in morning with both hands and arm numbness. Weakness throughout body that continued to get worse. Also developed rash on face, neck and back. Was worked up twice for lyme disease but test was negative. (b)(6) 2016 developed fever and whole body numbness. Had difficulty walking. Was treated with antibiotics for a month. Antibiotics finished in (b)(6). One week later is when i was hospitalized for small bowel obstruction. Was hospitalized for 10 days. During this hospitalization developed right upper thigh numbness. Previously reported this in (b)(6) 2016. Had small bowel obstruction in (b)(6) 2016. No previous abdominal surgeries except for umbilical hernia repair with ethicon physiomesh. There was 3 feet of small intestines removed. Continued to be uncomfortable and have pain after surgery. A 30 lb weight loss. After hospitalization had endoscopy, gastric emptying test, mre. All tests were negative. Also saw a neurologist because i continued to have right upper thigh numbness. Had mri of brain and spine ms protocol which was also negative. Continued to have abdominal pain and feel uncomfortable. On (b)(6) 2017 had surgery for removal of ethicon physiomesh. This mesh was adhered to the small intestine which was starting to obstruct again. Also had lysis of multiple adhesions. Still recovering from second surgery. Still have numbness in right upper thigh. Surgeon was able to remove entire body mesh robotically. First case in the united states done this way.
 
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Brand NameETHICON PHYSIOMESH FLEXIBLE COMPOSITE MESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
JOHNSON AND JOHNSON
MDR Report Key6521841
MDR Text Key73865099
Report NumberMW5069319
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 04/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHY1015V
Device Lot NumberHE8CDCB1
Was Device Available for Evaluation? No
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: 04/24/2017 Patient Sequence Number: 1
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