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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
Catalog Number PROMESHUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Incontinence (1928)
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 regarding the additional events. Citation: the american journal of surgery 188 (suppl to october 2004) 52s¿56s; doi: 10. 1016/j. Amjsurg. 2004. 08. 022. (b)(4).
 
Event Description
It was reported in a journal article with title: gynecologic use of robotically assisted laparoscopy: sacrocolpopexy for the treatment of high-grade vaginal vault prolapse. This study describes a novel minimally invasive technique of vaginal vault prolapse repair and present their initial experience. A total of 20 patients (mean age was 66, range, 47¿82 years) underwent a robot-assisted laparoscopic sacrocolpopexy for severe symptomatic vaginal vault prolapse. A prolene mesh is then attached to the sacral promontory and to the vaginal apex using nonabsorbable expanded polytetrafluoroethylene sutures. At the end of the case, the mesh material is covered by the peritoneum. Complications included recurrent grade 3 rectocele (n
=
1), small erosion of the synthetic cuff into the vagina (n
=
1) and incontinence (n
=
2). In conclusion, this novel technique for vaginal vault prolapse repair combines the advantages of open sacrocolpopexy with the decreased morbidity and improved cosmesis of laparoscopic surgery. It is associated with decreased hospital stay, low complication and conversion rates, and high rates of patient satisfaction.
 
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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 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8932576
MDR Text Key156315201
Report Number2210968-2019-86180
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPROMESHUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/26/2019 Patient Sequence Number: 1
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