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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE MESH 15X15CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PMM3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Inflammation (1932); Fluid Discharge (2686)
Event Date 12/29/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).   a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.     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: bmi at the time of index procedure. What was the onset date of the current symptoms following the index surgical procedure? other relevant patient history/concomitant medications. What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? what were the results of the mesh removal? was there any allergy testing performed? if yes, results?   if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported that a patient underwent a left indirect inguinal hernia repair procedure on (b)(6) 2020 and the mesh was implanted. It was reported that the patient suffered from erythema, inflammation and wound secretion after using the product in the surgery of repair of left indirect inguinal hernia with mesh on (b)(6) 2020. It was also reported that a surgery was given to remove the patch.
 
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Brand NamePROLENE MESH 15X15CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11248429
MDR Text Key229336526
Report Number2210968-2021-00781
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K962530
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 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPMM3
Device Lot NumberPBR499
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2019
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: 01/28/2021 Patient Sequence Number: 1
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