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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 Material Erosion (1214)
Patient Problems Erosion (1750); Fever (1858); Hematoma (1884); Incontinence (1928); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); 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: int urogynecol j; doi 10. 1007/s00192-009-0879-9. (b)(4).
 
Event Description
Journal article title : complications of transvaginal monofilament polypropylene mesh in pelvic organ prolapse repair. This retrospective case series aimed to document the intraoperative and postoperative complications associated with the use of transvaginal polypropylene mesh in the repair of pop from one surgeon. Between sep2005 and jul2007, 127 female patients (mean age sd of 63. 5±10. 2 years) underwent vaginal reconstructive surgery for anterior, posterior, and apical prolapse correction reinforced by monofilament polypropylene mesh. In the procedure, a trapezoid piece of gynecare polypropylene mesh (ethicon) in the reconstruction (anterior [n
=
74], posterior [n
=
27] and combined anterior-posterior [n
=
26]). Postoperative complications included de novo urinary incontinence (n
=
23) for which 16 required further surgery of suburethral slings, mesh erosion (n
=
13) which 11 required further surgery, prolapse in any pelvic compartment (n
=
9) four of them required repair, vaginal hematoma (n
=
7) which were managed conservatively and resolved in 6-8 weeks without any surgical measures, urinary tract infection (n
=
5), vaginal discharge (n
=
1), visceral erosion (n
=
1), granulation tissue (n
=
1) and febrile morbidity (n
=
1). The posterior wall mesh may have produced prolapse in uninvolved compartment when combined with apical support procedures. The postoperative buttocks pain was associated with sacrospinous ligament fixation. Concurrent vaginal hysterectomy is associated with increased risk of vaginal mesh erosion. Combined anterior and posterior vaginal mesh repair is an increased risk factor for intraoperative bleeding and blood transfusion.
 
Manufacturer Narrative
Pc-000236008 date sent to the fda: 07/29/2018 additional patient codes:.
 
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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 Key7730150
MDR Text Key115348120
Report Number2210968-2018-74709
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,Followup
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2018
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: 07/29/2018 Patient Sequence Number: 1
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