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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VYPRO MESH 15X15CM:: MESH, SURGICAL, POLYMERIC

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ETHICON INC. VYPRO MESH 15X15CM:: MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number XCPVMM1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Hernia (2240)
Event Date 06/17/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Date sent to the fda: 08/01/2022. This report is being submitted pursuant to the provisions of 21 cfr, part 803. This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by ethicon inc. , or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. (b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. 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 other relevant patient history/concomitant medications were any concomitant procedures performed? onset date/time of the pain from surgery location and character of the pain? is there any specific activity that precipitated the pain or eased the pain? was medical intervention given for the pain management? results? was the device removed? 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 was the mesh placed? (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 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? from the revision surgery, what are the surgical findings including: mesh location and integrity? any deficiency or anomaly of the mesh? if yes, please describe it. Any pictures available? product code and lot # what is the patient's current status?.
 
Event Description
It was reported that a patient underwent an incisional hernia repair on (b)(6) 2017 and the mesh was implanted. It was reported that the patient experienced pain and had a relapse incisional hernia. It was also reported that the patient had a revision surgery on (b)(6) 2022. Additional information has been requested.
 
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Brand NameVYPRO MESH 15X15CM::
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt 22841
GM 22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
9083863534
MDR Report Key15141931
MDR Text Key297035803
Report Number2210968-2022-06142
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K002672
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2022
Device Catalogue NumberXCPVMM1
Device Lot NumberKL8CPLS0
Was Device Available for Evaluation? No
Date Manufacturer Received07/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2016
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: 08/01/2022 Patient Sequence Number: 1
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