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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MERSILENE MESH 30X30CM MESH, SURGICAL

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ETHICON INC. MERSILENE MESH 30X30CM MESH, SURGICAL Back to Search Results
Catalog Number TS54S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abnormal Vaginal Discharge (2123); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Attempts are being made to retrieve the device. 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, weight, bmi at the time of index procedure date and name of initial surgical procedure the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? if applicable, will product be returned, return date, tracking information what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? what was the mesh excision date and surgical findings? does the surgeon allege a defect with the mesh that contributed to the event? please clarify? el2gb7m0 is not a valid lot in the system. Please confirm lot number?.

 
Event Description

It was reported that a patient underwent a mesh rectopexy on an unknown date and the mesh was implanted. It was reported that there was vaginal discharge 7 years after implant with no infection. It was reported that there was no evidence of vaginal or rectal mesh erosion at laparoscopy mesh peritonealised and incorporated. It was reported that serious peritoneal fluid was in pouch of douglas with small pinhole in posterior vaginal wall not in proximity to the mesh. It was reported that there was a mid third mesh excised, partial excision, and peritoneum and vaginal defect was closed. It was reported that the patient is now at risk of recurrent prolapse, and if ongoing problems, will need joint complex surgery with urogynae. It was also reported that there was vaginal discharge 19 months.

 
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Brand NameMERSILENE MESH 30X30CM
Type of DeviceMESH, SURGICAL
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
9082183429
MDR Report Key10310578
MDR Text Key202370888
Report Number2210968-2020-05474
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUK
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 07/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberTS54S
Device LOT NumberEL2GB7M0
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 Received07/31/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/21/2013
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: 07/22/2020 Patient Sequence Number: 1
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