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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MALLA PROLENE SMALL 6CM X 11CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. MALLA PROLENE SMALL 6CM X 11CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PMS3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Inflammation (1932); Itching Sensation (1943)
Event Date 10/21/2019
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. Patient symptoms manifestations (location, severity, appearance, systemic or local reaction). Date, time of onset of infection from the surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? what medical intervention was performed? results?.
 
Event Description
It was reported that a patient underwent a right indirect inguinal hernia repair on an unknown date and the mesh was implanted. It was reported that there was post-op inflammation. It was reported that the patient suffered from erythema, inflammation and itching on the wound after implanting the product in the surgery. It was also reported that anti-infective, anti-allergic medications were given to the patient after discontinuation of the product. Then the patient's condition changed better.
 
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Brand NameMALLA PROLENE SMALL 6CM X 11CM
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
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9417648
MDR Text Key170065259
Report Number2210968-2019-90589
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 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPMS3
Device Lot NumberMGQ150
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 Received12/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/25/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/05/2019 Patient Sequence Number: 1
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