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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 Abscess (1690); Hematoma (1884); Urinary Tract Infection (2120); Hematuria (2558)
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: ann acad med singapore 2006;35:875-81. (b)(4).
 
Event Description
Title:the effectiveness of transvaginal anterior colporrhaphy reinforced with polypropylene mesh in the treatment of severe cystocele. The aim of this retrospective study was to determine the effectiveness of transvaginal anterior colporrhaphy reinforced with prolene mesh in the treatment of severe or recurrent cystoceles by looking at their primary surgical outcomes as well as their complications. From april 2002 to december 2003, thirty-seven patients (mean age 66. 8 years, range 43-86) with severe cystoceles underwent transvaginal anterior colporrhaphy reinforced with prolene mesh. The peri-vesical fascia was then plicated in the midline, from the anterior to the posterior part of the cystocele, with a gap of at least 1 cm between the sutures, using 2-0 pds ii (polydioxanone monofilament absorbable suture manufactured by ethicon, johnson & johnson) in a continuous manner. A prolene mesh is cut to an appropriate size to cover the whole cystocele centrally. The wings of the mesh were cut 1 cm wide. The two ends of the mesh were then placed onto the fascia of the iliococcygeus muscle with an artery forceps. The central portion of the mesh was then sutured with 2-0 vicryl (polyglactin 910 braided absorbable suture manufactured by ethicon, johnson & johnson) at the 4 corners onto the peri-vesical tissues for anchoring purposes. Minimal trimming of the vaginal skin was performed and the skin was sutured with continuous 2-0 vicryl rapide (polyglactin 910 braided absorbable suture manufactured by ethicon, johnson & johnson). Complications included bladder perforation (n
=
1) which did not require further management, pyrexia (n
=
13), urinary tract infection (n
=
4), hematuria (n
=
1), asymptomatic denovo detrusor instability (n
=
2), vault hematoma (n
=
1) and pelvic abscess (n
=
1). In conclusion, transvaginal anterior colporrhaphy reinforced with a tension-free prolene mesh in the treatment of severe or recurrent cystoceles is simple, safe, easily performed and is associated with a low failure rate and morbidity.
 
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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 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8905980
MDR Text Key154730375
Report Number2210968-2019-85710
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
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 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2019
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 Received08/01/2019
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: 08/19/2019 Patient Sequence Number: 1
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