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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE 3D PATCH MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE 3D PATCH MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 3DPROUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Urinary Retention (2119); Peripheral Edema (4578)
Event Date 10/13/2007
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: chinese journal of modern operative surgery, oct. 2007, vol. 11, no. 5.
 
Event Description
It was reported in a journal article with title: application of board mesh plug & prolene 3d patch in inguinal hernia patients. The objective of this retrospective study was to compare the therapeutic effect of bard mesh plug and prolene 3d patch in inguinal hernia patients. From august 2005 to december 2006, tension-free hernia repair was performed in 125 patients. The patients then divided into two groups: plug group (male
=
57, female
=
8; mean age
=
53. 1 ± 4. 5 years) and 3d patch group (male
=
54, female
=
6; mean age
=
55. 2 ± 3. 5 years). In the 3d patch group, the hernaila sac was separated from a high position to the extraperitoneal fat. The diamond shaped part of the prolene 3d patch (ethicon) was put into the fascia defect or the inner ring and then expanded, and the flat part of the patch was fixed with suture. Reported complications included scrotal effusion (n
=
3); postoperative urinary retention (n
=
7); pain in the groin region (n
=
1). In conclusion, both bard mesh plug and prolene 3d patch can be used effectively in tension-free herniorrhaphy. Bard mesh plug adapts especially to the week peritoneum patients or peritoneum conglutinate with transversalis fascia severely while transversalis fascia defect is not that big. Prolene 3d patch adapts especially to the patients of big defect of transversalis fascia or hernia ring.
 
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Brand NamePROLENE 3D PATCH 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)
J-PAC MEDICAL
25 centre road
somersworth NH 03878
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11091600
MDR Text Key226254147
Report Number2210968-2020-10382
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K061533
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 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number3DPROUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
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: 12/29/2020 Patient Sequence Number: 1
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