6/2/2017

Im ·.

I

MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH MESH, SURGICAL

H( I.LI. . L \\'

More Information at https://hollislawfirm.com/case/hernia-mesh-lawsuit/physiomesh/

i

FDA Home3 Medical Devices4 Databases5

MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH MESH, SURGICAL

|Adverse |Recalls11 |PMA12|HDE13|Classification14|Standards15 6510(k) 7|DeNovo8|Registration & 9 10 Listing Events CFR Title 2116 |Radiation­Emitting Products17|X­Ray Assembler 18|Medsun Reports19|CLIA20|TPLC21

Back to Search Results ETHICON INC. PHYSIOMESH MESH, SURGICAL Event Date 01/14/2015 Event Type  Injury   Event Description It was reported that the patient underwent a hernia repair procedure on (b)(6) 2012 and mesh was implanted. In the beginning of 2014, the patient became severely ill with symptoms of a bowel obstruction, severe nausea, vomiting, abdominal pain, cramping and bloating. The patient experienced numerous hospitalizations and weight loss of 45 pounds as of 2015. Additional information has been requested. Manufacturer Narrative (b)(4). Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. This medwatch report is in response to receipt of maude event report (b)(4). Search Alerts/Recalls22 New Search  |  Submit an Adverse Event Report23

Brand Name PHYSIOMESH Type of Device MESH, SURGICAL Manufacturer (Section D)ETHICON INC. P.O. Box 151, Route 22 West Somerville NJ 08876 015 Manufacturer (Section G)ETHICON INC.­GMBH Robert­Koch Strasse 1 Norderstedt D­22 851 GERMANY D­22851 Manufacturer ContactMary Szaro Route 22 West Po Box 151 Somerville , NJ 08876 9082183464 MDR Report Key4841461 Report Number2210968­2015­07040 Device Sequence Number1 Product CodeFTL24 Report SourceManufacturer Source TypeOther,Consumer Reporter OccupationOther Type of ReportInitial Report Date05/20/2015 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received06/12/2015 Is This An Adverse Event Report?Yes Is This A Product Problem Report?No Device OperatorHealth Professional Was Device Available For Evaluation?No Is The Reporter A Health Professional?No Date Manufacturer Received05/19/2015 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4841461&pc=FTL

1/3

15.06 4841461 SBO, Nausea, Vomiting, 45Lbs Loss.pdf ...

15.06 4841461 SBO, Nausea, Vomiting, 45Lbs Loss.pdf. 15.06 4841461 SBO, Nausea, Vomiting, 45Lbs Loss.pdf. Open. Extract. Open with. Sign In. Main menu.

251KB Sizes 2 Downloads 79 Views

Recommend Documents

Vomiting&Diarrhea.pdf
If your child is vomiting... (with or without diarrhea). %POU XPSSZ JG ZPVS DIJME WPNJUT POMZ PODF PS UXJDF*G ZPVS DIJME WPNJUT B UIJSE UJNF.

Recruitment-of-1506-Posts-in-Revenue-Registration-Survey ...
... BY ORDER//. SECTION OFFICER. Page 2 of 2. Recruitment-of-1506-Posts-in-Revenue-Registration-Survey-Departments-Telangana-Government.pdf.

Recruitment-of-1506-Posts-in-Revenue-Registration-Survey ...
Whoops! There was a problem loading this page. Recruitment-of-1506-Posts-in-Revenue-Registration-Survey-Departments-Telangana-Government.pdf.

man-99\cyclic-vomiting-syndrome-and-being-pregnet.pdf ...
man-99\cyclic-vomiting-syndrome-and-being-pregnet.pdf. man-99\cyclic-vomiting-syndrome-and-being-pregnet.pdf. Open. Extract. Open with. Sign In.