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U.S. Department of Health and Human Services

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

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ETHICON INC. PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1520V
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
(b)(4) date sent to fda: 06/27/2016. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The patient demographic info: age, gender, weight, bmi at the time of index procedure what were current symptoms following the index surgical procedure? onset date? date of initial surgical procedure? date that the surgeon first noted the mesh was not incorporated? other relevant patient history/concomitant medications what is physician¿s opinion as to the etiology of or contributing factors to this event? was the hernia repair associated with this event performed on primary or recurrent hernia? mesh size and overlap? in what tissue layer did you place the mesh? (onlay, retro-muscular, extra peritoneal or intra-abdominal) if applicable, closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable? if applicable, the mesh fixation technique: device and technique? (single or double crown; spacing between implants) how was the event diagnosed? what is the patient¿s current status? has medical or surgical intervention been provided or scheduled? please provide dates and results. Photos show areas of mesh that are not incorporated. However, the reason for insufficient incorporation cannot be determined.
 
Event Description
It was reported that the patient underwent a laparoscopic inguinal hernia repair procedure on (b)(6) 2016 and mesh was implanted. Following the procedure, it was found that the mesh never integrated to the tissues. Additional information has been requested.
 
Manufacturer Narrative
In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
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Brand NamePHYSIOMESH OVAL
Type of DeviceMESH, 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
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5750573
MDR Text Key48201627
Report Number2210968-2016-09974
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Catalogue NumberPHY1520V
Device Lot NumberJM8DLXD0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/27/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2016 Patient Sequence Number: 1
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