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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC

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JOHNSON & JOHNSON INTERNATIONAL PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1015V
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hernia (2240); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.

 
Event Description

It was reported that the patient underwent a laparoscopic bilateral inguinal hernia repair procedure on (b)(6) 2015 and the mesh was implanted. Following the procedure, the patient experienced a recurrence of a left internal inguinal hernia in (b)(6) 2016 and underwent a re-operation. The doctor was not sure if the mesh was the reason of recurrence. No further information is available.

 
Manufacturer Narrative

Additional information was requested and the following was received: the patient demographic info: age, gender, weight, bmi at the time of index procedure: --- no information. What were current symptoms following the index surgical procedure. Onset date. --- no information. Other relevant patient history/concomitant medications. --- no information. What is physician¿s opinion as to the etiology of or contributing factors to this event. --- the physician¿s was not sure. The physician said the technique might be related to this event. There is no detailed information. Was the hernia repair associated with this event performed on primary or recurrent hernia. --- primary. What was the defect size/type/location of the hernia associated with this event. --- no information. Mesh size and overlap. --- no information. If applicable in what tissue layer did you place the mesh? (onlay, retro-muscular, extra peritoneal or. --- no information. Was there any triggering event prior to present recurrence? (e. G. Weight gain, sneezing, coughing, strenuous activity). --- no information. How was the recurrence diagnosed. --- no information. Please provide the date of reoperation. --- no information. Mesh location and integrity. --- no information. Was there any deficiency or anomaly of the mesh? if yes, please describe it. --- no information. Are there any pictures available. ---not available. What is the patient¿s current status. --- there was no problem.

 
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Brand NamePHYSIOMESH OVAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
JOHNSON & JOHNSON INTERNATIONAL
leonardo da vincilaan 15
diegem 1831
BE 1831
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM D-22851
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6209145
MDR Text Key63403602
Report Number2210968-2016-60118
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK093932
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 12/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2017
Device Catalogue NumberPHY1015V
Device LOT NumberJE8DJBB0
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 Received01/13/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/2015
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: 12/28/2016 Patient Sequence Number: 1
Treatment
SECURESTRAP
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