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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4). This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: actas urol esp. 2007; 31(10): 1141-1147. (b)(4).
 
Event Description
It was reported via a journal article"title : trans-obturator tape (tot) in the correction of stress urinary incontinence. Three-year experience with 200 patients. " author : pardo schanz j1,2, ricci arriola p2, tacla fernández x1, betancourt ortiz e. Citation: actas urol esp. 2007; 31(10): 1141-1147. The objectives of the study was to assess the safety and efficacy of the tot in the treatment of female stress urinary incontinence, according to the authors experience. This is a prospective study of 200 patients (age range: 34 to 78 years old) who underwent tot in the gynecology unit of the department of obstetrics and gynecology of the barros luco-trudeau hospital, between january 2003 and october 2006. A prolene monofilament mesh (ethicon) was used during the procedure. Reported complications included urinary infection (lower urinary tract infection; n-1) which required antibiotic therapy, lower extremity pain (n-3) which required analgesic drugs, displacement of the tape at the third month (n-1) which required new surgery, and failure of the surgery, maintaining the stress incontinence (n-10). The tot is a technique whose modifications compared to tvt, reduce the time of surgery and its complications. Tot is a safe and effective technique in the surgical correction of stress urinary incontinence.
 
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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
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 Key9199416
MDR Text Key166754995
Report Number2210968-2019-88701
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2019
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: 10/16/2019 Patient Sequence Number: 1
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