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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 PHY1520V
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Hernia (2240); No Code Available (3191)
Event Date 12/09/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 ventral hernia repair procedure on (b)(6) 2016 and the mesh was implanted. Two months after the procedure, the patient returned to the doctor, complaining the hernia had returned. On (b)(6) 2016, a re-operation was performed and it was discovered the mesh pulled away from the fixations and stay sutures and migrated into a ball in the omentum. Other mesh was used to repair the hernia with no patient consequences after the re-operation. 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. - i don¿t have this information. What were current symptoms following the index surgical procedure. Onset date. - not sure. Other relevant patient history/concomitant medications. - no. Product lot number. - i don¿t have this information. What is physician¿s opinion as to the etiology of or contributing factors to this event. - he¿s not sure, he has never seen anything like it. 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. - ventral hernia. Mesh size and overlap. - 6x8 (15x20cm). Was the procedure associated with this event open or laparoscopic. If applicable in what tissue layer did you place the mesh? (onlay, retro-muscular, extra peritoneal or intra abdominal). - laparoscopic. Closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable. - closed the defect with permanent suture. The mesh fixation technique: device and technique. (single or double crown; spacing between implants). - double crown. Was there any triggering event prior to present recurrence? (e. G. Weight gain, sneezing, coughing, strenuous activity). - no. How was the recurrence diagnosed. - patient came back into the office of dr. Saba and once examined, confirmed that the hernia reoccurred. Please provide the results of reoperation. - repaired with bard 6x8 (15x20cm) ventralight st. Mesh location and integrity. - ventral. Was any deficiency or anomaly of the mesh? if yes, please describe it. - physiomesh pulled completely away from the securestraps and waddled up into a ball in the momentum. Are there any pictures available. - none at this time. What is the patient¿s current status. - back to normal activities.
 
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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 Key6218126
MDR Text Key63722289
Report Number2210968-2017-60001
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHY1520V
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 Received01/06/2017
Was Device Evaluated by Manufacturer? No
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: 01/03/2017 Patient Sequence Number: 1
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