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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Migration (4003)
Patient Problems Erosion (1750); Blood Loss (2597); Not Applicable (3189)
Event Date 07/04/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. The patient demographic info: age, gender, weight, bmi at the time of index procedure. The diagnosis and indication for the index 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 medical/surgical intervention for exposure including dates. Please provide the date of reoperation. What were the findings on reoperation? were any deficiencies or anomalies noted with mesh device? are there any pictures available for evaluation? product code and lot #. What is the 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 the patient underwent a laparoscopic rectopexy and sacrocolpopexy procedure on (b)(6) 2018 and the mesh was implanted. The patient complicated due to rheumatoid arthritis, steroids, methotrexate and low bmi (15). Following recovery and discharge, the patient was readmitted with pr bleeding. It was found that the patient has a complete breakdown of anterior rectal wall with mesh exposed. Additional information has been requested.

 
Manufacturer Narrative

Pc-(b)(4). Additional information was requested, and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure na the diagnosis and indication for the index surgical procedure? (b)(4) 2018 any concurrent procedure/device implantation? na were there any intra-operative complications? na when was the mesh exposure first noted by a physician? (b)(4) 2018 mesh exposure site/location, symptoms and diagnostic confirmation? na describe medical/surgical intervention for exposure including dates. Please provide the date of reoperation. (b)(4) 2018 what were the findings on reoperation? patient had laparoscopic mesh rectopexy and lap sacro-colpopexy by colorectal and gynae on (b)(4) 2018. Patient complicated due to rheumatoid arthritis, steroids, methotrexate and low bmi ((b)(4)). Following recovery and discharge was readmitted with pr bleeding - found to have complete breakdown of anterior rectal wall with mesh exposed. Were any deficiencies or anomalies noted with mesh device? are there any pictures available for evaluation? na product code and lot # na what is the physician¿s opinion as to the etiology of or contributing factors to this event? na what is the patient¿s current status? na.

 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7818947
MDR Text Key118305646
Report Number2210968-2018-75446
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK962530
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 08/09/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received10/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/27/2018 Patient Sequence Number: 1
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