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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); Hematoma (1884); Incontinence (1928); Unspecified Infection (1930); Urinary Frequency (2275)
Event Date 08/07/2013
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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, demographics regarding the additional events. Citation: j obstet gynaecol can 2013;35(11):1004¿1009. Events for patients with tvt submitted via 2210968-2021-04569. Events for patients with polyproylene suture and prolene mesh submitted via 2210968-2021-04584.
 
Event Description
Title: outcome of the laparoscopic two-team sling procedure, tension-free vaginal tape insertion, and transobturator tape insertion in women with recurrent stress urinary incontinence. This retrospective cohort study aims to provide outcome data for various surgical techniques used at our centre for the treatment of recurrent stress urinary incontinence (sui), and to assess the immediate and long-term complications associated with these procedures. Between 2006 and 2011,a total of 46 women recurrent sui who underwent laparoscopic two team sling procedure, tension-free vaginal tape (tvt) insertion, or transobturator tape (tot) insertion for recurrent sui were inlcluded in the study. The surgical procedure chosen was at the discretion of the attending surgeon. Tvt insertion (gynecare tvt, ethicon endo-surgery inc. , somerville, nj) was performed in 15 women. The laparoscopic two-team sling procedure was performed as a combined vaginal and laparoscopic procedure, with a suburethral polypropylene mesh (ethicon) introduced vaginally and sutured to cooper¿s ligaments using non-absorbable 0 polypropylene suture (ethicon) in 24 women. The duration of follow-up ranged from 1. 5 to 60 months (mean 25) for women in the two-team sling group,and one to 63 months (mean 16) for women in the tvt group. Reported complications included : -(n
=
1) one woman had a subjective failure possibly because of proximal migration of the tape. Patients who had subjective failure of treatment in the tvt group (n
=
6), one woman who had a laparoscopic two-team sling procedure had persisting voiding dysfunction at her six week visit, necessitating prolonged clean intermittent self catheterization (n
=
1), one woman who had a laparoscopic two-team sling required re-admission because of an infected hematoma (n
=
1), it was concluded, that the laparoscopic two-team sling procedure, tvt insertion, or tot insertion may be used in experienced hands for surgical management of recurrent sui. No significant differences in outcome among the three groups , possibly because of the small sample size. Larger sample sizes and longer follow-up within prospective randomized trials are warranted to be able to reach solid conclusions.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11822099
MDR Text Key265241290
Report Number2210968-2021-04571
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
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 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
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 Received04/30/2021
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/13/2021 Patient Sequence Number: 1
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