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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 Material Erosion (1214)
Patient Problem Erosion (1750)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot. 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 the diagnosis and indication for the initial surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? mesh exposure site/location, symptoms and diagnostic confirmation? describe any medical/surgical intervention for exposure including dates and surgical findings. 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?.
 
Event Description
It was reported that a patient underwent a hysteropexy procedure on an unknown date and the mesh was implanted. It was reported that there were findings of foreign body in sigmoid colon, when having routine colonoscopy. It was reported that further examination revealed mesh erosion into the bowel wall with polyp arising from one edge. It was reported that the patient is asymptomatic. It was also reported that the patient was discussed at a colorectal mdt and there is low risk of developing sudden symptoms from rectum point of view. It is also reported that it is important to determine exact height of mesh entry into rectum, because if intraperitoneal, risks are higher, and the patient will need formal bowel resection once rectotomy is made to remove mesh. It was reported that if rectal resection is required there it may be possible to avoid stoma. It was reported that on mri, bowel is adherent to sacral promontory and it appears that it is distal sigmoid on endoscopy with mesh clearly on view; reassuring that it was unchanged on imaging in 2 years. It was reported that the device remains implanted.
 
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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
00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10653738
MDR Text Key210681472
Report Number2210968-2020-07773
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberPMM3
Device Lot NumberJBJ830
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/22/2015
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: 10/08/2020 Patient Sequence Number: 1
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