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U.S. Department of Health and Human Services

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

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ETHICON INC. PHYSIOMESH RECTANGULAR; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY3035R
Device Problems Failure To Adhere Or Bond (1031); Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Seroma (2069)
Event Type  Death  
Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Event Description
It was reported that the patient underwent an unknown procedure on unknown date and mesh was implanted.Following the procedure, the mesh was not integrated with the tissue allowing the development of persistent seroma.It was also reported that the patient died.Additional information has been requested.
 
Manufacturer Narrative
It was reported that the patient underwent a hernia ventral repair procedure on unknown date and mesh was implanted.
 
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Brand Name
PHYSIOMESH RECTANGULAR
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM   D-22851
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key5258164
MDR Text Key32412355
Report Number2210968-2015-19359
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2015
Device Catalogue NumberPHY3035R
Device Lot NumberHA8JLQB0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/11/2015
Initial Date FDA Received12/01/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/18/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/31/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
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