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U.S. Department of Health and Human Services

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

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ETHICON INC. PHYSIOMESH UNKNOWN PRODUCT MESH, SURGICAL Back to Search Results
Catalog Number PHYSIOMUNK
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Hernia (2240)
Event Date 10/13/2017
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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. 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 was the hernia repair associated with this event performed on primary or recurrent hernia? what was the defect size/type/location of the hernia associated with this event? mesh size and overlap? 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). 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). Were there any surgical instruments used in the placement of the mesh that might have damaged the mesh? e. G. Graspers crimping the mesh fibers. How much time from initial hernia repair to hernia recurrence? was there any triggering event prior to present recurrence? (e. G. Weight gain, sneezing, coughing, strenuous activity)? how was the recurrence diagnosed? "if reoperation, surgical findings: please provide the date of reoperation mesh location and integrity. Was any deficiency or anomaly of the mesh? if yes, please describe it. Are there any pictures available?" how many hernia repairs have you performed using the device?.
 
Event Description
It was reported that a patient underwent a hernia repair procedure on (b)(6) 2015 and the mesh was implanted. It was reported that the device did not stick to the abdominal wall as expected, and there was a recurrence. It was reported that the recurrence was possibly related to the device and to the registry procedure.
 
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Brand NamePHYSIOMESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt 22851
GM 22851
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9253052
MDR Text Key164839260
Report Number2210968-2019-89204
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,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPHYSIOMUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/29/2019 Patient Sequence Number: 1
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